Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02018536 | A Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2336805 Alone and With the Co-administration of TMC435 in Healthy Japanese Participants. | PHASE1 | COMPLETED | 48 | — | — | Oct 1, 2013 | Mar 1, 2014 | Jun 17, 2014 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Part 1, Cohort A | EXPERIMENTAL | 8 participants to receive a single oral dose of 30 mg of GSK2336805 (6 participants) or placebo (2 participants) on Day 1. |
| Part 1, Cohort B | EXPERIMENTAL | 8 participants to receive a single oral dose of 60 mg of GSK2336805 (6 participants) or placebo (2 participants) on Day 1. |
| Part 1, Cohort C | EXPERIMENTAL | 8 participants to receive a single oral dose of 120 mg of GSK2336805 (6 participants) or placebo (2 participants) on Day 1. |
| Part 2, Sequence 1 | EXPERIMENTAL | 6 participants to receive Treatment A (TMC435 150 mg), D (TMC435 150 mg+GSK2336805 60 mg), B (GSK2336805 60 mg), and C (TMC435 100 mg+GSK2336805 60 mg) in a sequence with a 7 days washout period between each treatment sessions. |
| Part 2, Sequence 2 | EXPERIMENTAL | 6 participants to receive Treatment B (GSK2336805 60 mg), A (TMC435 150 mg), C (TMC435 100 mg+GSK2336805 60 mg), and D (TMC435 150 mg+GSK2336805 60 mg) in a sequence with a 7 days washout period between each treatment sessions. |
| Part 2, Sequence 3 | EXPERIMENTAL | 6 participants to receive Treatment C (TMC435 100 mg+GSK2336805 60 mg), B (GSK2336805 60 mg), D (TMC435 150 mg+GSK2336805 60 mg), and A (TMC435 150 mg) in a sequence with a 7 days washout period between each treatment sessions. |
| Part 2, Sequence 4 | EXPERIMENTAL | 6 participants to receive Treatment D (TMC435 150 mg+GSK2336805 60 mg), C (TMC435 100 mg+GSK2336805 60 mg), A (TMC435 150 mg) and B (GSK2336805 60 mg) in a sequence with a 7 days washout period between each treatment sessions. |
| Name | Type | Description |
|---|---|---|
| GSK2336805 30 mg | DRUG | A single dose of 1 tablet of 30 mg of GSK2336805 taken orally (by mouth) on Day 1 under fasted conditions. |
| GSK2336805 60 mg | DRUG | A single dose of 2 tablets of 30 mg ie, 60 mg of GSK2336805 taken orally (by mouth) on Day 1 under fasted conditions. |
| GSK2336805 120 mg | DRUG | A single dose of 4 tablets of 30 mg ie, 120 mg of GSK2336805 taken orally (by mouth) on Day 1 under fasted conditions. |
| TMC435 150 mg (Treatment A) | DRUG | 1 capsule of TMC435 150 mg taken once daily orally (by mouth) on Days 1 to 7 under fed conditions. |
| GSK2336805 60 mg (Treatment B and part of Treatment C and D) | DRUG | 2 tablets of 30 mg GSK2336805 ie, 60 mg of GSK2336805 taken once daily orally (by mouth) on Days 1 to 7 under fed conditions. |
| TMC435 100 mg (part of Treatment C) | DRUG | 1 capsule of TMC435 100 mg taken orally (by mouth) on Days 1 to 7 under fed conditions. |
| TMC435 150 mg (part of treatment D) | DRUG | 1 capsule of TMC435 150 mg taken orally (by mouth) on Days 1 to 7 under fed conditions. |
Inclusion Criteria: * Healthy Japanese participants on the basis of medical history, physical examination, vital signs, triplicate 12-lead electrocardiogram, and clinical laboratory testing performed at screening * Must have signed an Informed Consent Form (ICF) indicating they understand the purpo...