Phase I, double-blind, randomized, placebo-controlled trial to examine the safety, tolerability and plasma pharmacokinetics of increasing single oral doses of TMC558445 with and without food, and increasing repeated oral doses in combination with a single dose of TMC310911.

Phase I, double-blind, randomized, placebo-controlled trial to examine the safety, tolerability and plasma pharmacokinetics of increasing single oral doses of TMC558445 with and without food, and increasing repeated oral doses in combination with a single dose of TMC310911. - Phase I trial to examine TMC558445 and TMC310911.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33802

Enrollment

Registered

2009-01-26

Start date

2009-02-17

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: Will consist of 6 sessions (Sessions I to VI). Nine subjects will take part in Sessions I, III and V (Panel 1), and 9 other subjects take part in Sessions II, IV and VI (Panel 2). In ea

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) 18-60 years; 2) Nonsmoker; 3) BMI 18.0-30.0; 4) Signed ICF 5) Able to comply with protocol requirements 6) Healthy based on the basis of a medical evaluation.

Exclusion criteria

Exclusion criteria: 1) History of clinically significant heart arrhythmias; 2) Female except if they are of non-childbearing potential; 3) History or evidence of alcohol and or drug abuse ; 4) Hepatitis A, B en C; 5) Positive urine drug test; 6) Currently active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease; 7) Any history of significant skin disease such as but not limited to rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis or urticaria 8) History of drug allergy; 9) Use of concomitant medication, except for paracetamol and ibuprofen in the 14 before first trial medication intake; 10) Participation in an investigational drug trial within 60 days prior to the first intake of trial medication; 11) Donation of blood plasma within the 60 days preceding the first intake of trial medication; 12) Lab abnormalities.

Design outcomes

Primary

Measure	Time frame
Single dose: The objectives are to examine the safety, tolerability and pharmacokinetics (i.e., the circulating levels of TMC558445 in your blood over time) of increasing single oral doses of TMC558445, with and without food. Multiple dose: The objectives of Part 2 (multiple dose escalation part) are to examine the safety, tolerability and pharmacokinetics of increasing repeated oral doses of TMC558445, followed by a single dose of TMC558445 together with TMC310911 or DRV to assess whether the combined intake of TMC558445 with TMC310911 or DRV increases the circulating levels of TMC310911 or DRV in blood.	—

Measure

Time frame

Single dose: The objectives are to examine the safety, tolerability and pharmacokinetics (i.e., the circulating levels of TMC558445 in your blood over time) of increasing single oral doses of TMC558445, with and without food. Multiple dose: The objectives of Part 2 (multiple dose escalation part) are to examine the safety, tolerability and pharmacokinetics of increasing repeated oral doses of TMC558445, followed by a single dose of TMC558445 together with TMC310911 or DRV to assess whether the combined intake of TMC558445 with TMC310911 or DRV increases the circulating levels of TMC310911 or DRV in blood.

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)