A Phase 2 interventional study of GSK557296 and GSK557296 in Premature Ejaculation, sponsored by GlaxoSmithKline. Completed at 8 sites in 2 countries. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-09-12.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
To determine if an on demand dosing of 50 mg or 150 mg of GSK557296 demonstrates superior efficacy with respect to duration of intra vaginal ejaculatory latency time (IELT) during an 8 week study period compared to placebo in men with primary premature ejaculation. An assessment of the safety and tolerability of all doses of GSK557296 will be performed as well as an assessment for change in the Index of Premature Ejaculation (IPE) from baseline and at the end of the 8 weeks of treatment. During the active treatment period study participants will be limited to a maximum of 40 doses of GSK557296, or placebo, spilt as 20 doses for both 4 week intervals.
106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.
This study's enrollment of 77 is close to the median of 84 across 89 interventional studies indexed under Premature Ejaculation.
Browse Premature Ejaculation studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Previous or Current Medical Conditions
Concomitant Medications
Abnormal Laboratory Values
Other exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
placebo
Drug: placebo
50 mg GSK557296
Drug: GSK557296
150 mg GSK557296
Drug: GSK557296
Mean Intravaginal Ejaculatory Latency Time (IELT) Compared Over All 8 Weeks of Treatment or Until Premature Discontinuation
Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p \< 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05).
Time frame: Up to Week 8
Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation
Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p \< 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05).
Time frame: Up to Week 8
Mean IELT Compared After the First Dose of Study Drug or Placebo
Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. First dose IELT was the IELT value associated with the first valid SI attempt made during the treatment period. For GSK557296 50 mg and 150 mg: LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster using placebo, GSK557296 50 mg and GSK557296 150 mg treatments. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p \< 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05).
Time frame: Up to Week 8
Mean Change From Baseline in IELT Compared After Each 4-week Treatment Period and Over All 8 Weeks or Until Premature Discontinuation
Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. Baseline IELT was calculated as the arithmetic mean IELT from valid screening SI attempts. If multiple screening SI attempts were made on the same calendar day, only the IELT from the first attempt was used in the calculation of Baseline IELT. Change from Baseline IELT was calculated by subtracting the Baseline IELT (arithmetic mean IELT from valid screening attempts) from the on-treatment IELT (median IELT from valid on-treatment attempts). Only participants with a Baseline and a post-Baseline IELT value were included.
Time frame: Baseline and up to Week 8
Mean Change From Baseline in IELT Compared After the First Dose of Study Drug or Placebo
Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. First dose IELT was the IELT value associated with the first valid SI attempt made during the treatment period. Baseline IELT was calculated as the arithmetic mean IELT from valid screening SI attempts. If multiple screening SI attempts were made on the same calendar day, only the IELT from the first attempt was used in the calculation of Baseline IELT. Change from Baseline IELT was calculated by subtracting the Baseline IELT (arithmetic mean IELT from valid screening attempts) from the on-treatment IELT (median IELT from valid on-treatment attempts). Only participant with a Baseline IELT and a valid first attempt were included.
Time frame: Baseline and Week 4
Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC(0-inf)] and From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration [AUC(0-t)] of GSK557296
The pharmacokinetic (PK ) visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded.
Time frame: At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization
Maximum Observed Plasma Concentration (Cmax) of GSK557296
The PK visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded.
Time frame: At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization
Time of Occurrence of Maximum Observed Plasma Concentration (Tmax) of GSK557296
The PK visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded.
Time frame: At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were taken in a seated position. If the single measure was outside the cut off value, the mean of three seated measures were taken approximately 5-10 minutes apart was recorded. Baseline value was the latest values obtained on or before the Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline. Per-participant values for all vital sign measures were taken as the mean of all reported values on a given date, regardless of recorded position.
Time frame: Baseline and up to follow up (post treatment 48 hours)
Mean Change From Baseline in Heart Rate
Heart rate assessment was done in a seated position. If the single measure was outside the cut off value, the mean of three seated measures were taken approximately 5-10 minutes apart was recorded. Baseline value was the latest values obtained on or before the Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline. Per-participant values for all vital sign measures were taken as the mean of all reported values on a given date, regardless of recorded position.
Time frame: Baseline and up to follow up (post treatment 48 hours)
Mean Change From Baseline in Electrocardiogram (ECG) Values
ECG parameter values for QT interval, QT duration corrected for heart rate by Fridericia's formula (QTc \[Fridericia\]), QT duration corrected for heart rate by Bazett's formula (QTc \[Bazett\]), PR Interval and QRS Duration were assessed. The Baseline ECG was the latest ECG recorded on or before the participant's Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline.
Time frame: Baseline and up to follow up (post treatment 48 hours)
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry)
Serum laboratory parameters: Albumin, Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Direct bilirubin, Total Bilirubin (T. Bilirubin), Calcium, Chloride, Carbon dioxide content/Bicarbonate (CO2/HCO3), Creatinine, Gamma glutamyl transferase (GGT), Glucose, Potassium, Sodium, Total protein (T. Protein), Urea/Blood urea nitrogen (BUN) and Uric acid were assessed. Baseline laboratory values were the latest values obtained on or before the participant's Baseline reference date. Unscheduled laboratory values were summarized as at-visit values only in the event that an at-visit laboratory value was missing. The values were presented as high, low or normal values shifted from Baseline value.
Time frame: Baseline and up to follow up (post treatment 48 hours)
Number of Participants With Shift From Baseline in Additional Lab Parameters (Free T3, Prostate Specific Antigen [PSA], Thyroid Stimulating Hormone [TSH] and Total Testosterone)
Baseline laboratory values were the latest values obtained on or before the participant's Baseline reference date. Unscheduled laboratory values were summarized as at-visit values only in the event that an at-visit laboratory value was missing. The values were presented as high, low or normal values shifted from Baseline value.
Time frame: Baseline and up to follow up (post treatment 48 hours)
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. On-treatment adverse events were those started on or after the first dose of study medication and on or before the last dose of study medication.
Time frame: Baseline and up to follow up (post treatment 48 hours)
Number of Participants With Dose/Exposure Response Relationship Using PK/Pharmacodynamics (PD) Modeling
The relationship between plasma concentrations of GSK557296 and selected endpoints were planned to be explored using appropriate PK/PD models.
Time frame: Up to Week 8
The study was conducted at 6 sites in United States and 2 centers in the Netherlands during 23 December 2009 to 05 May 2011.
| Milestone | Placebo | GSK557296 50 mg | GSK557296 150 mg |
|---|---|---|---|
| Started | 27 | 22 | 28 |
| Completed | 23 | 17 | 25 |
| Not completed | 4 | 5 | 3 |
| Withdrew: Adverse event | 1 | 0 | 0 |
| Withdrew: Lack of efficacy | 2 | 2 | 0 |
| Withdrew: Protocol violation | 0 | 2 | 2 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 |
Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p \< 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05).
| minutes | Placebo | GSK557296 50 mg | GSK557296 150 mg | Pooled GSK557296 |
|---|---|---|---|---|
| Mean Intravaginal Ejaculatory Latency Time (IELT) Compared Over All 8 Weeks of Treatment or Until Premature Discontinuation | 0.62 ± 0.090 | 0.72 ± 0.117 | 0.69 ± 0.099 | 0.71 ± 0.075 |
Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p \< 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05).
| minutes | Placebo | GSK557296 50 mg | GSK557296 150 mg | Pooled GSK557296 |
|---|---|---|---|---|
| Week 0 to 4 | 0.67 ± 0.095 | 0.69 ± 0.109 | 0.67 ± 0.094 | 0.68 ± 0.071 |
| Week 4 to 8 | 0.65 ± 0.110 | 0.86 ± 0.168 | 0.70 ± 0.118 | 0.77 ± 0.097 |
Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. First dose IELT was the IELT value associated with the first valid SI attempt made during the treatment period. For GSK557296 50 mg and 150 mg: LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster using placebo, GSK557296 50 mg and GSK557296 150 mg treatments. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p \< 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05).
| minutes | Placebo | GSK557296 50 mg | GSK557296 150 mg | Pooled GSK557296 |
|---|---|---|---|---|
| Mean IELT Compared After the First Dose of Study Drug or Placebo | 0.60 ± 0.116 | 0.68 ± 0.146 | 0.57 ± 0.109 | 0.61 ± 0.088 |
Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. Baseline IELT was calculated as the arithmetic mean IELT from valid screening SI attempts. If multiple screening SI attempts were made on the same calendar day, only the IELT from the first attempt was used in the calculation of Baseline IELT. Change from Baseline IELT was calculated by subtracting the Baseline IELT (arithmetic mean IELT from valid screening attempts) from the on-treatment IELT (median IELT from valid on-treatment attempts). Only participants with a Baseline and a post-Baseline IELT value were included.
| minutes | Placebo | GSK557296 50 mg | GSK557296 150 mg | Pooled GSK557296 |
|---|---|---|---|---|
| Week 0 to 4 | 0.29 ± 0.510 | 0.74 ± 2.061 | 1.26 ± 3.493 | 1.03 ± 2.939 |
| Week 4 to 8 | 0.38 ± 0.940 | 1.24 ± 2.869 | 1.30 ± 2.853 | 1.27 ± 2.823 |
| Week 0 to 8 | 0.26 ± 0.481 | 0.91 ± 2.406 | 1.24 ± 3.085 | 1.10 ± 2.786 |
Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. First dose IELT was the IELT value associated with the first valid SI attempt made during the treatment period. Baseline IELT was calculated as the arithmetic mean IELT from valid screening SI attempts. If multiple screening SI attempts were made on the same calendar day, only the IELT from the first attempt was used in the calculation of Baseline IELT. Change from Baseline IELT was calculated by subtracting the Baseline IELT (arithmetic mean IELT from valid screening attempts) from the on-treatment IELT (median IELT from valid on-treatment attempts). Only participant with a Baseline IELT and a valid first attempt were included.
| minutes | Placebo | GSK557296 50 mg | GSK557296 150 mg | Pooled GSK557296 |
|---|---|---|---|---|
| Mean Change From Baseline in IELT Compared After the First Dose of Study Drug or Placebo | 0.33 ± 0.750 | 0.73 ± 2.003 | 0.93 ± 3.191 | 0.84 ± 2.713 |
The pharmacokinetic (PK ) visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded.
| Hours times nanograms per milliliters | GSK557296 50 mg | GSK557296 150 mg |
|---|---|---|
| AUC (0-inf) | 854.1 ± 45 | 2485.9 ± 33 |
| AUC (0-t) | 772.9 ± 43 | 2304.2 ± 31 |
The PK visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded.
| Nanograms per milliliter (ng/mL) | GSK557296 50 mg | GSK557296 150 mg |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of GSK557296 | 387.2 ± 49 | 1405.1 ± 41 |
The PK visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded.
| hours | GSK557296 50 mg | GSK557296 150 mg |
|---|---|---|
| Time of Occurrence of Maximum Observed Plasma Concentration (Tmax) of GSK557296 | 0.6 ± 43 | 0.4 ± 51 |
SBP and DBP were taken in a seated position. If the single measure was outside the cut off value, the mean of three seated measures were taken approximately 5-10 minutes apart was recorded. Baseline value was the latest values obtained on or before the Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline. Per-participant values for all vital sign measures were taken as the mean of all reported values on a given date, regardless of recorded position.
| Millimeters of mercury | Placebo | GSK557296 50 mg | GSK557296 150 mg |
|---|---|---|---|
| SBP, Week 4 | 0.422 ± 8.5478 | -2.472 ± 9.3388 | -0.550 ± 8.8500 |
| SBP, Week 8 | 1.290 ± 9.1774 | -0.657 ± 11.1552 | -4.268 ± 13.4694 |
| DBP, Week 4 | -0.226 ± 7.5436 | -2.036 ± 7.3751 | -0.485 ± 6.7274 |
| DBP, Week 8 | 0.188 ± 7.8127 | 1.529 ± 6.9245 | -0.897 ± 8.8300 |
Heart rate assessment was done in a seated position. If the single measure was outside the cut off value, the mean of three seated measures were taken approximately 5-10 minutes apart was recorded. Baseline value was the latest values obtained on or before the Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline. Per-participant values for all vital sign measures were taken as the mean of all reported values on a given date, regardless of recorded position.
| Beats per minute | Placebo | GSK557296 50 mg | GSK557296 150 mg |
|---|---|---|---|
| Week 4 | 0.319 ± 8.4404 | 1.821 ± 10.5332 | 3.240 ± 9.8555 |
| Week 8 | 2.428 ± 6.9642 | 2.221 ± 6.2480 | 0.279 ± 7.8860 |
ECG parameter values for QT interval, QT duration corrected for heart rate by Fridericia's formula (QTc \[Fridericia\]), QT duration corrected for heart rate by Bazett's formula (QTc \[Bazett\]), PR Interval and QRS Duration were assessed. The Baseline ECG was the latest ECG recorded on or before the participant's Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline.
| Milliseconds | Placebo | GSK557296 50 mg | GSK557296 150 mg |
|---|---|---|---|
| QT Interval, Week 4 | 1.8 ± 19.52 | -2.5 ± 25.42 | -0.1 ± 21.35 |
| QT Interval, Week 8 | -3.1 ± 17.16 | -0.4 ± 20.17 | -4.9 ± 21.12 |
| QTc (Fridericia), Week 4 | 1.5 ± 11.98 | -3.1 ± 12.77 | -9.2 ± 13.18 |
| QTc (Fridericia), Week 8 | -5.7 ± 8.07 | 5.4 ± 7.23 | -3.6 ± 17.42 |
| QTc (Bazett), Week 4 | 0.4 ± 18.50 | -1.0 ± 15.80 | -4.2 ± 16.07 |
| QTc (Bazett), Week 8 | -1.7 ± 15.88 | 3.4 ± 17.52 | -4.2 ± 17.38 |
| PR Interval, Week 4 | -2.6 ± 7.32 | -3.1 ± 10.05 | 1.0 ± 15.22 |
| PR Interval, Week 8 | -2.5 ± 10.40 | -3.1 ± 9.49 | 0.4 ± 15.88 |
| QRS Duration, Week 4 | -1.9 ± 5.17 | 2.1 ± 7.40 | 0.6 ± 8.38 |
| QRS Duration, Week 8 | -2.0 ± 4.99 | 1.0 ± 4.15 | 1.3 ± 8.35 |
Serum laboratory parameters: Albumin, Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Direct bilirubin, Total Bilirubin (T. Bilirubin), Calcium, Chloride, Carbon dioxide content/Bicarbonate (CO2/HCO3), Creatinine, Gamma glutamyl transferase (GGT), Glucose, Potassium, Sodium, Total protein (T. Protein), Urea/Blood urea nitrogen (BUN) and Uric acid were assessed. Baseline laboratory values were the latest values obtained on or before the participant's Baseline reference date. Unscheduled laboratory values were summarized as at-visit values only in the event that an at-visit laboratory value was missing. The values were presented as high, low or normal values shifted from Baseline value.
| Participants | Placebo | GSK557296 50 mg | GSK557296 150 mg |
|---|---|---|---|
| Albumin, Week 4, high to normal | 2 | 1 | 1 |
| Albumin, Week 4, normal to high | 1 | 2 | 0 |
| Albumin, Week 4, low to normal | 1 | 0 | 0 |
| Albumin, Week 8, high to normal | 1 | 1 | 1 |
| Albumin, Week 8, normal to high | 1 | 1 | 1 |
| Albumin, Week 8, low to normal | 1 | 0 | 0 |
| AP, Week 4, high to normal | 0 | 0 | 1 |
| AP, Week 4, normal to high | 0 | 0 | 1 |
| AP, Week 8, high to normal | 0 | 0 | 1 |
| ALT, Week 4, high to normal | 1 | 0 | 0 |
| ALT, Week 4, normal to high | 1 | 1 | 1 |
| ALT, Week 8, high to normal | 2 | 0 | 0 |
| ALT, Week 8, normal to high | 0 | 1 | 1 |
| AST, Week 4, normal to high | 0 | 1 | 2 |
| AST, Week 8, normal to high | 0 | 1 | 0 |
| T. Bilirubin, Week 4, normal to high | 2 | 1 | 2 |
| T. Bilirubin, Week 4, high to normal | 0 | 0 | 4 |
| T. Bilirubin, Week 8, high to normal | 2 | 0 | 4 |
| T. Bilirubin, Week 8, normal to high | 0 | 1 | 2 |
| Calcium, Week 4, high to normal | 1 | 0 | 0 |
| Calcium, Week 4, normal to high | 1 | 0 | 1 |
| Calcium, Week 4, low to normal | 1 | 0 | 0 |
| Calcium, Week 8, high to normal | 1 | 0 | 0 |
| Calcium, Week 8, normal to high | 2 | 0 | 2 |
| Calcium, Week 8, low to normal | 1 | 0 | 0 |
| Chloride, Week 4, high to normal | 1 | 0 | 0 |
| Chloride, Week 4, normal to high | 1 | 2 | 0 |
| Chloride, Week 8, high to normal | 1 | 0 | 0 |
| Chloride, Week 8, normal to high | 1 | 0 | 0 |
| CO2/HCO3, Week 4, normal to low | 2 | 0 | 1 |
| CO2/HCO3, Week 4, low to normal | 2 | 3 | 2 |
| CO2/HCO3, Week 8, normal to low | 1 | 0 | 2 |
| CO2/HCO3, Week 8, low to normal | 2 | 3 | 1 |
| Creatinine, Week 4, normal to high | 1 | 0 | 0 |
| Creatinine, Week 8, normal to high | 1 | 0 | 0 |
| GGT, Week 4, high to normal | 0 | 0 | 1 |
| GGT, Week 4, normal to high | 0 | 0 | 1 |
| GGT, Week 8, high to normal | 0 | 0 | 1 |
| GGT, Week 8, normal to high | 0 | 0 | 2 |
| Glucose, Week 4, high to normal | 1 | 2 | 1 |
| Glucose, Week 4, normal to high | 3 | 2 | 2 |
| Glucose, Week 4, low to normal | 1 | 0 | 1 |
| Glucose, Week 4, normal to low | 0 | 1 | 0 |
| Glucose, Week 8, high to normal | 2 | 1 | 3 |
| Glucose, Week 8, normal to high | 2 | 4 | 1 |
| Glucose, Week 8, low to high | 1 | 0 | 0 |
| Glucose, Week 8, low to normal | 0 | 0 | 1 |
| Potassium, Week 4, low to normal | 1 | 0 | 0 |
| Potassium, Week 8, low to normal | 1 | 0 | 0 |
| Sodium, Week 4, high to normal | 0 | 1 | 1 |
| Sodium, Week 4, normal to high | 0 | 1 | 0 |
| Sodium, Week 8, high to normal | 0 | 1 | 1 |
| T. Protein, Week 8, low to normal | 1 | 0 | 0 |
| Urea/BUN, Week 4, high to normal | 0 | 0 | 1 |
| Urea/BUN, Week 4, normal to high | 0 | 0 | 1 |
| Urea/BUN, Week 4, low to normal | 0 | 0 | 1 |
| Urea/BUN, Week 8, high to normal | 0 | 0 | 1 |
| Uric acid, Week 4, high to normal | 1 | 1 | 0 |
| Uric acid, Week 4, normal to high | 1 | 0 | 2 |
| Uric acid, Week 4, low to normal | 1 | 0 | 0 |
| Uric acid, Week 4, normal to low | 0 | 0 | 1 |
| Uric acid, Week 8, normal to high | 1 | 0 | 0 |
| Uric acid, Week 8, low to normal | 1 | 0 | 0 |
| Uric acid, Week 8, high to normal | 0 | 1 | 0 |
| Uric acid, Week 8, normal to low | 0 | 0 | 1 |
Baseline laboratory values were the latest values obtained on or before the participant's Baseline reference date. Unscheduled laboratory values were summarized as at-visit values only in the event that an at-visit laboratory value was missing. The values were presented as high, low or normal values shifted from Baseline value.
| Participants | Placebo | GSK557296 50mg | GSK557296 150mg |
|---|---|---|---|
| Free T3, Week 4, high to nomal | 0 | 1 | 0 |
| Free T3, Week 8, high to nomal | 0 | 1 | 0 |
| TSH, Week 4, normal to low | 0 | 1 | 0 |
| TSH, Week 8, normal to high | 0 | 1 | 0 |
| Testosterone, Week 8, normal to low | 1 | 1 | 1 |
AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. On-treatment adverse events were those started on or after the first dose of study medication and on or before the last dose of study medication.
| Participants | Placebo | GSK557296 50 mg | GSK557296 150 mg |
|---|---|---|---|
| Any AEs | 8 | 6 | 10 |
| Any SAEs | 0 | 0 | 0 |
The relationship between plasma concentrations of GSK557296 and selected endpoints were planned to be explored using appropriate PK/PD models.
No measurements were reported for this outcome.
Collected over All SAEs and non SAEs were collected through out the study treatment (8 weeks) and up to follow up (post treatment 48 hours). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/25 (0%) | 0/25 (0%) | 8/25 (32%) |
| GSK557296 50 mg | 0/22 (0%) | 0/22 (0%) | 6/22 (27.3%) |
| GSK557296 150 mg | 0/28 (0%) | 0/28 (0%) | 10/28 (35.7%) |
| Event | Placebo | GSK557296 50 mg | GSK557296 150 mg |
|---|---|---|---|
| HeadacheNervous system disorders | 3/25 | 3/22 | 5/28 |
| PresyncopeNervous system disorders | 2/25 | 0/22 | 0/28 |
| NasopharyngitisInfections and infestations | 2/25 | 0/22 | 1/28 |
| Influenza like illnessGeneral disorders | 1/25 | 1/22 | 0/28 |
| IrritabilityGeneral disorders | 0/25 | 1/22 | 0/28 |
| BlepharospasmEye disorders | 0/25 | 1/22 | 0/28 |
| Procedural painInjury, poisoning and procedural complications | 0/25 | 1/22 | 0/28 |
| InsomniaPsychiatric disorders | 0/25 | 1/22 | 0/28 |
| Tooth extractionSurgical and medical procedures | 0/25 | 1/22 | 0/28 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 1/25 | 0/22 | 1/28 |
| Age, Continuous(Years) | Placebo | GSK557296 50 mg | GSK557296 150 mg | Total |
|---|---|---|---|---|
| Mean | 38.4 ± 8.90 | 37.9 ± 9.85 | 34.0 ± 9.00 | 36.7 ± 9.31 |
| Sex: Female, Male(Participants) | Placebo | GSK557296 50 mg | GSK557296 150 mg | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 27 | 22 | 28 | 77 |
| Race (NIH/OMB)(Participants) | Placebo | GSK557296 50 mg | GSK557296 150 mg | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 1 |
| Black or African American | 2 | 2 | 3 | 7 |
| White | 24 | 20 | 21 | 65 |
| More than one race | 0 | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Studies of the drug tested here: Epelsiban