A Phase 1 interventional study of IX-01 caplets 1600 mg (4 x 400 mg), fasted and IX-01 caplets 1600 mg (4 x 400 mg), fed in Healthy, sponsored by Ixchelsis Limited. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-13.
Sponsored by Ixchelsis Limited · Phase 1, Interventional, and Basic science
An open-label, randomized, three-period, three-way crossover trial of single doses of IX-01 in 12 healthy male subjects. In each period, subjects will receive a single oral dose of 1600 mg IX-01, either as an aqueous dispersion in a fasted state, or as caplets in the fed or fasted state
This is a Relative Bioavailability Study to compare single oral doses of 1600mg IX-01, either as an aqueous dispersion in a fasted state, or as caplets in the fed or fasted state. Each volunteer in the study will receive each of the formulations listed below. Each formulation will be separated by at least a 5-day drug-free (washout) period.
In the fasted treatment periods, dosing will follow an overnight fast of at least 10 hours.
In the fed treatment period, following an overnight fast of at least 10 hours, a standard high-calorie, high-fat breakfast meal will be given 30 minutes prior to administration of the study drug.
There will be a final follow-up visit 7-10 days after the final dose of study medication.
Ixchelsis Limited is the lead sponsor of 6 studies on the registry; none are open to participants now.
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:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
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.
A single 1600 mg (4 x 400 caplets) oral dose of IX-01 under fasted conditions
Drug: IX-01 caplets 1600 mg (4 x 400 mg), fasted
A single 1600 mg (4 x 400 caplets) oral dose of IX-01 under fed conditions
Drug: IX-01 caplets 1600 mg (4 x 400 mg), fed
A single 1600 mg aqueous dispersion (20 mL) oral dose of IX-01 under fasted conditions.
Drug: IX-01 aqueous dispersion 1600 mg (20 mL), fasted
oral dose under fasted conditions
oral dose under fed conditions
oral dose under fasted conditions
Pharmacokinetic parameter peak plasma concentration of IX-01 (C max)
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Pharmacokinetic parameter time of peak plasma concentration of IX-01 (t max)
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Pharmacokinetic parameter terminal half-life (t 1/2)
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Pharmacokinetic parameter elimination rate constant (K el)
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Relative bioavailability of the caplet formulation of IX-01 compared with the aqueous dispersion formulation (fasted)
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Pharmacokinetic parameter area under the concentration-time curve (AUC 0-inf)
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
area under the concentration-time curve from 0 up to the time of last quantifiable concentration (AUC last)
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the fasted state
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
The relative bioavailability of IX-01, as judged by AUC 0-inf (F rel)
Relative bioavailability of the caplet formulation of IX-01 compared with the aqueous dispersion formulation when administered in the fasted state
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Comparison of Maximum Plasma Concentration [Cmax] in fed versus fasted states
To determine the effect of a high-fat meal on the pharmacokinetic profile of the IX-01 caplet formulation
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Comparison of Area Under the Curve [AUC] in fed versus fasted states
To determine the effect of a high-fat meal on the pharmacokinetic profile of the IX-01 caplet formulation
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Comparison of Time to Maximum Plasma Concentration [Tmax] in fed versus fasted states
To determine the effect of a high-fat meal on the pharmacokinetic profile of the IX-01 caplet formulation
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Comparison of the Area Under the Curve [AUC] in fed versus fasted states
To determine the effect of a high-fat meal on the pharmacokinetic profile of the IX-01 caplet formulation
Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Safety monitoring - adverse events, laboratory data, ECGs, vital signs
To monitor the safety and tolerability of IX-01
Time frame: Day 0 to Day 21
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Nov 2016, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: IX-01
Ixchelsis Limited