A single dose study to evaluate the microdose pharmacokinetics of candidate HIV integrase strand transfer inhibitors in healthy subjects
Completed
- Conditions
- HIV-11002146010047438
- Registration Number
- NL-OMON42414
- Lead Sponsor
- Merck Sharp & Dohme (MSD)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
healthy male volunteers
18 - 45 yrs, inclusive
BMI: 18.5-32 kg/m2, inclusive
non-smoking
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To obtain preliminary plasma pharmacokinetic data (including AUC0-*, AUC0-last,<br /><br>Cmax, Tmax, apparent terminal t*, Cl, Vd) of single intravenous<br /><br>microdoses of L-1, L-2, and L-3 in healthy subjects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the safety and tolerability of single intravenous microdoses of<br /><br>L-1, L-2, and L-3 in healthy subjects.</p><br>