Cholestasis
Conditions
Keywords
tolerability, healthy volunteers, Cholestasis, safety
Brief 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.
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
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 64 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as assessed by Electrocardiogram (ECG) | Maximum of 5 weeks | 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. |
| Safety as assessed by clinical chemistry parameters | Maximum of 5 weeks | Blood sample will be collected on Day -1, at 48 hrs in each period and at follow-up |
| Number of Subjects with Adverse events (AE) | Maximum of 5 weeks | — |
| Safety as assessed by blood pressure | Maximum of 5 weeks | 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. |
| Safety as assessed by heart rate | Maximum of 5 weeks | 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. |
| Safety as assessed by body temperature | Maximum of 5 weeks | 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. |
| Safety as assessed by haematology | Maximum of 5 weeks | Blood sample will be collected on Day -1, at 48 hrs in each period and at follow-up |
| Safety as assessed by urinalysis | Maximum of 5 weeks | Sample will be collected on Day -1, at 48 hrs in each period and at follow-up |
| Safety as assessed by fecal occult blood | Maximum of 5 weeks | Fecal occult blood testing will be conducted on Screening (2 samples during Screening period) and each dosing period (anytime from dosing to next dose). |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration of GSK2330672 | 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 |
Countries
Japan
Outcome results
None listed