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A Study to Investigate the Effect of GSK1605786 on Hepatic Cytochrome P450, and BCRP and OATP1B1 Transport in Healthy Adult Subjects

NCT01489943 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-07-25

No results posted yet for this study

Summary

The purpose of this study is to test the effects of study drug (GSK1605786) on the blood levels of multiple commonly used drugs that are given to measure how your liver breaks down the study drug. These commonly-used drugs are midazolam, pioglitazone, omeprazole, and rosuvastatin which will determine the effect of GSK1605786 on how the body breaks down (metabolizes) these commonly-used drugs. Blood samples for pharmacokinetic analysis of GSK1605786, and two metabolites, \[GSK2635622 (CCX062) and GSK2656694 (CCX304)\] and four probe substrates will be collected over a 24-hour period after administration. Safety will be assessed by the measurement of vital signs, cardiac monitoring, collection of adverse event assessments and laboratory tests.

Conditions

Interventions

DRUG

GSK1605786 500 mg

Subjects will receive 500 milligram (mg) (2 doses of 250 mg) GSK1605786 hard gelatin capsules twice daily orally on Days 5 to 14. GSK1605786 will be administered with 240 milliliter (mL) of water.

DRUG

Midazolam 3 mg

Subjects will receive 3 mg oral syrup of Midazolam once daily on Day 1 and Day 11. Midazolam will be administered with 240 mL of water.

DRUG

Pioglitazone 15 mg

Subjects will receive 15 mg tablet of pioglitazone orally once daily on Day 2 and Day 12. Pioglitazone will be administered with 240 mL of water.

DRUG

Omeprazole 40 mg

Subjects will receive 40 mg hard gelatin capsules of Omeprazole once daily on Days 3 and 13. Omeprazole will be administered with 240 mL of water.

DRUG

Rosuvastatin 10 mg

Subjects will receive 10 mg tablet of Rosuvastatin orally once daily on Days 4 and 14. Rosuvastatin will be administered with 240 mL of water.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-19
Primary Completion
2011-11-10
Completion
2011-11-10

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01489943 on ClinicalTrials.gov