A Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2336805 Alone and With the Co-administration of TMC435 in Healthy Japanese Participants.

NCT02018536 | Completed Phase 1

• 2 other identifiers: CR102928TMC435HPC1012
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate the safety, tolerability, and pharmacokinetic (what the body does to a medication) of GSK2336805 alone and with the co-administration of TMC435 in healthy Japanese participants.

Conditions

Healthy

Keywords

Healthy; TMC435; GSK2336805; Pharmacokinetic; Safety; Tolerability

Outcome Measures

Primary Outcomes (9)

• Part 1: Maximum observed plasma concentration of GSK2336805

  Predose, postdose on Day 1 (0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours), Day 2 (24 and 36 hour), Day 3, and time point of early withdrawal

• Part 1: Area under the plasma concentration-time curve of GSK2336805

  Predose, postdose on Day 1 (0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours), Day 2 (24 and 36 hour), Day 3, and time point of early withdrawal

• Part 1: The actual sampling time to reach the maximum observed plasma concentration of GSK2336805

  Predose, postdose on Day 1 (0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours), Day 2 (24 and 36 hour), Day 3, and time point of early withdrawal

• Part 2: Maximum observed plasma concentration of TMC435

  Predose, postdose on Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 2, Day 5, Day 6, Day 7 (predose and postdose (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 8, Day 9, Day 10, and time point of early withdrawal

• Part 2: Area under the plasma concentration-time curve of TMC435

  Predose, postdose on Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 2, Day 5, Day 6, Day 7 (predose and postdose (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 8, Day 9, Day 10, and time point of early withdrawal

• Part 2: The actual sampling time to reach the maximum observed plasma concentration of TMC435

  Predose, postdose on Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 2, Day 5, Day 6, Day 7 (predose and postdose (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 8, Day 9, Day 10, and time point of early withdrawal

• Part 2: Maximum observed plasma concentration of GSK2336805

  Predose, postdose on Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 2, Day 5, Day 6, Day 7 (predose and postdose (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 8, Day 9, Day 10, and time point of early withdrawal

• Part 2: Area under the plasma concentration-time curve of GSK2336805

  Predose, postdose on Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 2, Day 5, Day 6, Day 7 (predose and postdose (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 8, Day 9, Day 10, and time point of early withdrawal

• Part 2: The actual sampling time to reach the maximum observed plasma concentration of GSK2336805

  Predose, postdose on Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 2, Day 5, Day 6, Day 7 (predose and postdose (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 8, Day 9, Day 10, and time point of early withdrawal

Secondary Outcomes (1)

• Part 1 and 2: Number of participants with adverse events

  Up to 12-14 weeks

Study Arms (7)

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.

Drug: GSK2336805 30 mg

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.

Drug: GSK2336805 60 mg

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.

Drug: GSK2336805 120 mg

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.

Drug: TMC435 150 mg (Treatment A); Drug: GSK2336805 60 mg (Treatment B and part of Treatment C and D); Drug: TMC435 100 mg (part of Treatment C); Drug: TMC435 150 mg (part of treatment D)

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.

Drug: TMC435 150 mg (Treatment A); Drug: GSK2336805 60 mg (Treatment B and part of Treatment C and D); Drug: TMC435 100 mg (part of Treatment C); Drug: TMC435 150 mg (part of treatment D)

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.

Drug: TMC435 150 mg (Treatment A); Drug: GSK2336805 60 mg (Treatment B and part of Treatment C and D); Drug: TMC435 100 mg (part of Treatment C); Drug: TMC435 150 mg (part of treatment D)

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.

Drug: TMC435 150 mg (Treatment A); Drug: GSK2336805 60 mg (Treatment B and part of Treatment C and D); Drug: TMC435 100 mg (part of Treatment C); Drug: TMC435 150 mg (part of treatment D)

Interventions

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.

Part 1, Cohort A

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.

Part 1, Cohort B

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.

Part 1, Cohort C

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.

Part 2, Sequence 1; Part 2, Sequence 2; Part 2, Sequence 3; Part 2, Sequence 4

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.

Part 2, Sequence 1; Part 2, Sequence 2; Part 2, Sequence 3; Part 2, Sequence 4

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.

Part 2, Sequence 1; Part 2, Sequence 2; Part 2, Sequence 3; Part 2, Sequence 4

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.

Part 2, Sequence 1; Part 2, Sequence 2; Part 2, Sequence 3; Part 2, Sequence 4

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 purpose of and procedures required for the study
• Must be willing to adhere to the prohibitions and restrictions specified in the protocol
• Women must be of non-childbearing potential (postmenopausal for at least 2 years or surgically sterile)
• Women, except for postmenopausal women, should have a negative serum b-human chorionic gonadotropin (hCG) pregnancy test at screening

You may not qualify if:

• History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use within the past one year
• Participants with hepatitis A, B, or C infection or human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection at study screening
• Female participants who are breastfeeding at screening
• History of liver or renal impairment; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
• Participants with known allergies, hypersensitivity, or intolerance to GSK2336805, TMC435 or excipients of the drug products used

Sponsors & Collaborators

• Janssen R&D Ireland: lead

Study Sites (1)

Unknown Facility

Cypress, California, United States

Location

MeSH Terms

Interventions

GSK2336805; Simeprevir; Fumigant 93

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Janssen R&D Ireland Clinical Trial

  Janssen R&D Ireland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 23, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 17, 2014

Record last verified: 2014-06

Locations

US (1)