CompletedNCT02801981Updated Nov 9, 2016

Dose-escalation Study of GSK2330672 in Japanese Healthy Male Volunteers

A Phase 1 interventional study of GSK2230672 and Placebo in Cholestasis, sponsored by GlaxoSmithKline. Completed at 1 site in Japan. Open to male participants aged 20 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-09.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 16
Allocation: Randomized
Ages: 20 Years to 64 Years
Sex: Male

Study summary

This study will be the first to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics following single dose of 10 milligrams (mg) to 180 mg of GSK2330672 in Japanese healthy subjects. This is a double-blind, randomized, placebo-controlled, dose-escalating and incomplete block crossover study to be conducted in 16 Japanese healthy subjects. Study will be conducted in four periods; subjects will receive either placebo or GSK2330672 (10 mg, 30 mg, 90 mg or 180 mg based on randomization) in each treatment period. Each period will be separated by washout period (at least 6 days from dosing). Total duration of study for each subject will be approximately 5 weeks from the first dosing to follow up visit.

Conditions studied

Cholestasis

Browse trials for

Cholestasis 220

Keywords

tolerability
healthy volunteers
Cholestasis
safety

In context

Cholestasis

220 studies on the registry are indexed under Cholestasis; 37 are open to participants now.

This study's enrollment of 16 is below the median of 55 across 135 interventional studies indexed under Cholestasis.

Browse Cholestasis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 64 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

Japanese male aged between 20 and 64 years of age inclusive, at the time of signing the informed consent
Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECG. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator (in consultation with the Medical Monitor if required) agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Regular bowel movement >=1 per two days.
Body weight >= 50 kilogram and body mass index (BMI) is more than or equal to 18.5 kilogram / square meter (kg/m\^2) and less than 25.0 kg/m\^2
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.

Exclusion criteria

Exclusion Criteria:

Alanine transaminase (ALT) and/or bilirubin >1.5x Upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome)
QT interval corrected for heart rate according to Fridericia's formula (QTcF) > 450 millisecond (msec)
Current or chronic history of inflammatory bowel disease, chronic diarrhea, Crohn's disease or malabsorption syndromes.
Current or chronic history of cholelithiasis, inflammatory gall bladder disease, cholestatic liver injury, and cholecystecomy.
Fecal occult blood test positive at screening.
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (includes St. John's Wort) within 14 days or 5 half-lives, whichever is longer, prior to the first dose of study medication.
History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 drinks. One drink is equivalent to 12 grams (g) of alcohol: 350 millilitre (mL) of beer, 150 mL of wine or 45 mL of 80 proof distilled spirits.
History or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
History of sensitivity to heparin or heparin-induced thrombocytopenia.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation
A positive pre-study syphilis, Hepatitis B surface antigen, Hepatitis C antibody, Human Immunodeficiency Virus (HIV) antigen antibody or Human T-cell Lymphotropic Virus-1 (HTLV-1) antibody result of screening
A positive pre-study urine drug screen.
History of donation of blood or blood products >= 400 mL within 3 months or >= 200 mL within 1 month prior to screening.
The subject has participated in a clinical trial and has received an investigational product within four months or 5 half-lives (whichever is longer) prior to the dosing day in the current study
Exposure to more than four new chemical entities within 12 months prior to the dosing day.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 16 participants (actual)

Study arms

Experimental
Sequence 1: GSK2230672 10mg, 30mg, 90mg, and Placebo
Subjects will receive GSK2230672 10 mg in period 1, GSK2230672 30 mg in Period 2, GSK2230672 90 mg in Period 3 and placebo in period 4.
Drug: GSK2230672 · Drug: Placebo
Experimental
Sequence 2:GSK2230672 10mg, 30mg, Placebo, and GSK2230672 90mg
Subjects will receive GSK2230672 10 mg in period 1, GSK2230672 30 mg in Period 2, placebo in period 3, and GSK2230672 90 mg in period 4.
Drug: GSK2230672 · Drug: Placebo
Experimental
Sequence 3:GSK2230672 10mg, Placebo, GSK2230672 90mg and 180mg
Subjects will receive GSK2230672 10 mg in period 1, placebo in Period 2, GSK2230672 90 mg in Period 3 and GSK2230672 180 mg in period 4.
Drug: GSK2230672 · Drug: Placebo
Experimental
Sequence 4: Placebo, GSK2230672 30mg, 90mg and 180mg
Subjects will receive placebo in period 1, GSK2230672 30 mg in Period 2, GSK2230672 90 mg in Period 3 and GSK2230672 180 mg in period 4.
Drug: GSK2230672 · Drug: Placebo

Interventions

DrugGSK2230672
It will be supplied as white to slightly colored, round, film coated tablet for oral administration containing 10 mg or 45 mg of GSK2330672.
DrugPlacebo
It will be supplied as placebo tablets (with no GSK2230672) visually matching to GSK2230672

What researchers measure

Primary outcomes

Number of Subjects with Adverse events (AE)
Time frame: Maximum of 5 weeks
Safety as assessed by blood pressure
Systolic and diastolic blood pressure will be measured on Day -1, post dose 2 hours (hrs), 12.5 hrs, 24.5 hrs and at 48 hrs in each period and at follow-up.
Time frame: Maximum of 5 weeks
Safety as assessed by heart rate
Heart rate will be measured on Day -1, post dose 2 hrs, 12.5 hrs, 24.5 hrs and at 48 hrs in each period and at follow-up.
Time frame: Maximum of 5 weeks
Safety as assessed by body temperature
Body temperature will be measured on Day -1, post dose 2 hrs, 12.5 hrs, 24.5 hrs and at 48 hrs in each period and at follow-up.
Time frame: Maximum of 5 weeks
Safety as assessed by clinical chemistry parameters
Blood sample will be collected on Day -1, at 48 hrs in each period and at follow-up
Time frame: Maximum of 5 weeks
Safety as assessed by haematology
Blood sample will be collected on Day -1, at 48 hrs in each period and at follow-up
Time frame: Maximum of 5 weeks
Safety as assessed by urinalysis
Sample will be collected on Day -1, at 48 hrs in each period and at follow-up
Time frame: Maximum of 5 weeks
Safety as assessed by fecal occult blood
Fecal occult blood testing will be conducted on Screening (2 samples during Screening period) and each dosing period (anytime from dosing to next dose).
Time frame: Maximum of 5 weeks
Safety as assessed by Electrocardiogram (ECG)
Electrocardiogram will be measured on Day -1, post dose 2 hrs, 12.5 hrs, 24.5 hrs and at 48 hrs in each period and at follow-up.
Time frame: Maximum of 5 weeks

Secondary outcomes

Plasma concentration of GSK2330672
Time frame: Blood samples will be collected predose and post dose at 0.5 hrs, 2 hr, 3.5 hr, 5 hr on Day 1 of each period

Study locations

1 site

GSK Investigational Site
Tokyo, 192-0071, Japan

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02801981
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Jun 16, 2016
Start date: Jun 2016
Primary completion: Aug 2016
Completion: Aug 2016
Last update: Nov 9, 2016

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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