TMC 125 Blood Levels Study

This study has been completed.
Sponsor:
Information provided by:
St Stephens Aids Trust
ClinicalTrials.gov Identifier:
NCT00531323
First received: September 17, 2007
Last updated: September 4, 2008
Last verified: September 2008

September 17, 2007
September 4, 2008
September 2007
Not Provided
Steady state plasma concentrations of TMC125 administered once and twice-daily and following a 2-week-treatment period with efavirenz 600 mg once daily [ Time Frame: 56 days ]
Same as current
Complete list of historical versions of study NCT00531323 on ClinicalTrials.gov Archive Site
Efavirenz inducing effect on TMC125 metabolism after efavirenz intake cessation evaluation. Safety and tolerability of TMC125 administered once and twice-daily [ Time Frame: 56 days ]
Efavirenz inducing effect on TMC125 metabolism after efavirenz intake cessation evaluation Safety and tolerability of TMC125 administered once and twice-daily [ Time Frame: 56 days ]
Not Provided
Not Provided
 
TMC 125 Blood Levels Study
Evaluation of the Pharmacokinetics and Safety of TMC125 Administered Once and Twice-Daily and Following a 2-Week-Treatment Period With Efavirenz in Male and Female Healthy Volunteers.

The purpose of the study is to look at whether changing directly from one medication for HIV (efavirenz) to a new medication for HIV (TMC125) has any effect on the levels of TMC125 in the blood, compared to when TMC125 is taken without efavirenz having been taken immediately beforehand.

The study aims to help the investigators understand whether it is safe to change directly from efavirenz to TMC125 (with no gap between the treatments) in patients who need these treatments.

The study will investigate the blood levels of TMC125 when it is taken both once and twice a day.

Pharmacokinetic parameters of TMC125 will be evaluated when TMC125 is given without and with a 14-day efavirenz intake preceding period in order to evaluate the risk of achieving sub therapeutic concentrations of TMC125 when switching straight from efavirenz containing regimens

Safety and tolerability of medications will also be assessed by questions, physical examination and laboratory parameters. These will be performed at regular intervals during the drug study.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
HIV Infections
  • Drug: TMC125 once daily
    Group 1 (n =12): subjects will receive TMC125 400 mg once daily for 14 days followed by 14 days of washout followed by efavirenz 600 mg once daily for 14 days followed by 14 days of TMC125 400 mg once daily
  • Drug: TMC125 twice daily
    Group 2 (n = 12): TMC125 200 mg twice daily for 14 days followed by 14 days of washout followed by efavirenz 600 mg once daily for 14 days followed by 14 days of TMC125 200 mg twice daily
  • 1
    Group 1 (n =12): subjects will receive TMC125 400 mg once daily for 14 days followed by 14 days of washout followed by efavirenz 600 mg once daily for 14 days followed by 14 days of TMC125 400 mg once daily
    Intervention: Drug: TMC125 once daily
  • 2
    Group 2 (n = 12): TMC125 200 mg twice daily for 14 days followed by 14 days of washout followed by efavirenz 600 mg once daily for 14 days followed by 14 days of TMC125 200 mg twice daily
    Intervention: Drug: TMC125 twice daily
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2007
Not Provided

Inclusion Criteria:

  1. The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
  2. Male or non-pregnant, non-lactating females
  3. Between 18 to 65 years, inclusive
  4. Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive
  5. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month after the study

Exclusion Criteria:

  1. Any significant acute or chronic medical illness
  2. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
  3. Positive blood screen for hepatitis B and/or C antibodies
  4. Positive blood screen for HIV-1 and 2 antibodies
  5. Current or recent (within 3 months) gastrointestinal disease
  6. Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study.
  7. Exposure to any investigational drug or placebo within 4 weeks of first dose of study drug
  8. Consumption of grapefruit, or Seville oranges or any grapefruit or Seville orange containing product within 1 week of first dose of study drug and for the duration of the study
  9. Use of any other drugs, including over-the-counter medications and herbal preparations, within 2 weeks prior to first dose of study drug
  10. Females of childbearing potential without the use of effective non-hormonal birth control methods, or not willing to continue practising these birth control methods for at least 30 days after the end of the treatment period
  11. Previous allergy to any of the constituents of the pharmaceuticals administered in this trial
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00531323
SSAT 024
No
Not Provided
St Stephens Aids Trust
Not Provided
Principal Investigator: Marta Boffito Chelsea & Westminser Healthcare NHS Trust
St Stephens Aids Trust
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP