Phase I, double-blind, randomized, placebo-controlled trial in healthy volunteers to examine the safety, tolerability and plasma pharmacokinetics of TMC589337 and TMC589354 after increasing single oral doses and in an open-label part after different repeated oral doses in combination with a single oral dose of TMC310911.

Phase I, double-blind, randomized, placebo-controlled trial in healthy volunteers to examine the safety, tolerability and plasma pharmacokinetics of TMC589337 and TMC589354 after increasing single oral doses and in an open-label part after different repeated oral doses in combination with a single oral dose of TMC310911. - A Phase I trial with TMC589337, TMC589354 and TMC310911.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33338

Enrollment

Registered

2009-04-21

Start date

2009-05-20

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS HIV

Interventions

Single Dose: The SAD part of the study consists of Panel 1 and 2. In both panels, the subjects will take 4 increasing oral doses of the study drug (active or placebo) in 4 seperate sessions. Each do

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged between 18 and 55 years, extremes included. 2. Non smokers for at least 3 months prior to selection. 3. Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, extremes included. 4. Informed consent signed voluntarily. 5. Able to comply with protocol requirements. 6. Healthy on basis of a pre-trial physical examination, medical history, the results of blood biochemistry and hematology tests, a urinalysis, vital signs and an ECG.

Exclusion criteria

Exclusion criteria: 1. Past history of significant heart arrhythmias. 2. Female, except if postmenopausal for more than 2 years, or posthysterectomy or post-surgical sterilization (without reversal operation). 3. History of alcohol or drug abuse. 4. Hepatitis A, B or C infection of HIV-1 or HIV-2 infection at trial screening. 5. A positive urine drug test at screening. 6. Currently active clinically relevant or significant underlying gastro-intestinal-, cardiovascular-, nervous system-, psychiatric-, metabolic-, renal-, hepatic-, respiratory-, inflammatory-, or infectious disease. 7. History of clinically relevent skin disease such as but not limited to dermatitis, eczema, drug allergy, psoriasis, food allergy, urticaria. 8. History of drug allergy such as but not limited to sulfonamides and penicillins or drug allergy witnessed in previous trials with experimental drugs. 9. Use of concomitant medication, except for paracetamol (acetaminophen) and ibuprofen in a period of 14 days before the first trial medication intake. 10. Participation in an investigational drug trial within 90 days (after last intake) prior to the first intake of trial medication. 11. Donation of blood or plasma in the 60 days preceding the first intake if trial medication. 12. Subjects with lababnormalities at screening.

Design outcomes

Primary

Measure	Time frame
The safety, tolerability and behavior in the body (absorption and excretion) of oral intake of TMC589337 and TMC589354 after ascending single intakes. The safety, tolerability and behavior in the body after multipe dose intakes of TMC589337 and/or TMC589354 in combination with a single dose of TMC310911 will be examined.	—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)