drugset
drugset / Trial / NCT00838760

PEPI-TiDP23-C103: First-in-Human Study to Examine the Safety, Tolerability, and Plasma Pharmacokinetics of Increasing Single and Repeated Oral Doses of TMC558445 and of a Combined Single Day Dosing of Oral TMC558445 and Oral TMC310911 and Also Oral Darunavir

NCT00838760 ↗

Phase 1 Completed 54 enrolled Tibotec Pharmaceuticals, Ireland
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to determine the safety, tolerability and plasma pharmacokinetics (pk) (i.e., the levels of TMC558445 circulating in your blood over time) of increasing single oral doses of TMC558445 and of multiple increasing oral doses followed by a single dose of TMC310911 to assess the potential boosting effect on the latter compound. In this study, two investigational new drugs are involved, TMC558445 and TMC310911. The study has been amended as follows: TMC558445 will be administered either twice a day (b.i.d.) or once daily (q.d.). A single 300 mg or 600 mg dose of TMC310911 will be administered under fasted or fed conditions. The boosting effect on Darunavir will be investigated.

Timeline

Start
2009-02
Primary completion
2009-10
Completion
2009-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Darunavir Small molecule 800 mg Oral
Subject TMC310911 Small molecule 300 mg Oral
Subject TMC310911 Small molecule 600 mg Oral
Subject TMC558445 Unknown 40 mg Oral
Subject TMC558445 Unknown 100 mg Oral
Subject TMC558445 Unknown 200 mg Oral
Subject TMC558445 Unknown 400 mg Oral
Subject TMC558445 Unknown 800 mg Oral
Subject TMC558445 Unknown 1600 mg Oral

Indications

No indication recorded.