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Adjusted LOA
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GSK2336805 · 1 trial · 1 indication
| 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...
GSK2336805 is an investigational small molecule being developed by Johnson & Johnson (JNJ). It is currently in Phase 1 clinical development. The drug has been studied in healthy participants to evaluate its safety, tolerability, and pharmacokinetics, both alone and in combination with another drug.
GSK2336805 is being studied for use in healthy participants. The completed Phase 1 trial focused on assessing the safety, tolerability, and pharmacokinetics of the drug when administered alone and with co-administration of TMC435. Its intended therapeutic use has not been specified in available data.
GSK2336805 is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company conducted a Phase 1 clinical trial to investigate the drug's safety, tolerability, and pharmacokinetics in healthy Japanese participants.
GSK2336805 is in Phase 1 clinical development. One Phase 1 trial has been completed, involving 48 healthy participants. The study was randomized, double-blind, and controlled, and it took place in the United States.
GSK2336805 has one completed clinical trial, registered as NCT02018536. The study investigated the safety, tolerability, and pharmacokinetics of GSK2336805 alone and with co-administration of TMC435 in healthy Japanese participants. The trial enrolled 48 participants and was completed.