PEPI-TiDP23-C104 is a First in Human Study With a Single Dose Escalation Part and a Multiple Dosing Part for Compounds TMC589337 and TMC589354.

Summary

The purpose of the study is to determine the safety, tolerability, and plasma pharmacokinetics (i.e., the levels of TMC589337 and TMC589354 circulating in your blood over time) of increasing single oral doses of TMC589337 and TMC589354 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 3 investigational new drugs are involved. These new investigational drugs called TMC589337 and TMC589354 (from the PEPI family) and TMC310911 are in process of development for the treatment of Human Immunodeficiency Virus-Type 1 (HIV-1). TMC589337 and TMC589354 are novel molecules with no antiviral activity to be used to enhance the pharmacokinetics profile of a drug. TMC310911 is a novel and potent compound and belongs to a medication class called protease inhibitors (PI).

Conditions

• HIV Infections

Interventions

DRUG

TMC589337 40 mg

Participants will receive TMC589337 40 mg in Session Ia of Panel 1.

DRUG

TMC589337 100 mg

Participants will receive TMC589337 100 mg in Session IIa of Panel 1.

DRUG

TMC589337 200 mg

Participants will receive TMC589337 200 mg in Session IIIa of Panel 1.

DRUG

TMC589337 400 mg

Participants will receive TMC589337 400 mg in Session IVa of Panel 1.

DRUG

TMC589354 40 mg

Participants will receive TMC589354 40 mg in Session Ib of Panel 2.

DRUG

TMC589354 100 mg

Participants will receive TMC589354 100 mg in Session IIb of Panel 2.

DRUG

TMC589354 200 mg

Participants will receive TMC589354 200 mg in Session IIIb of Panel 2.

DRUG

TMC589354 400 mg

Participants will receive TMC589354 400 mg in Session IVb of Panel 2.

DRUG

TMC589337 AA mg

Participants will receive TMC589337 AA mg on Days 1 to 7 in Session Va of Panel 3.

DRUG

TMC589354 BB mg

Participants will receive TMC589354 BB mg on Days 1 to 7 in Session Vb of Panel 4.

DRUG

TMC589337 CC mg

Participants will receive TMC589337 CC mg on Days 1 to 7 in Session VIa of Panel 5.

DRUG

TMC589354 DD mg

Participants will receive TMC589354 DD mg on Days 1 to 7 in Session VIb of Panel 6.

DRUG

TMC589337 EE mg

Participants will receive TMC589337 EE mg on Days 1 to 7 in Session VII of Panel 7.

DRUG

TMC589354 YY mg

Participants will receive TMC589354 YY mg on Days 1 to 7 in Session VII of Panel 7.

DRUG

TMC310911 300 mg

Participants will receive TMC310911 300 mg in Panel 3, 4, 5, 6 and 7.

DRUG

TMC310911 600 mg

Participants will receive TMC310911 600 mg in Panel 7.

DRUG

Placebo

Participants will receive matching placebo to TMC589337 or TMC589354 in Panel 1 and 2.

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland

  lead INDUSTRY

Principal Investigators

• Tibotec Pharmaceuticals Limited Clinical Trial · Tibotec Pharmaceutical Limited

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-05-31

Primary Completion

2009-10-31

Completion

2009-10-31

Countries

• Netherlands

Study Locations