A single dose study to evaluate the microdose pharmacokinetics of candidate HIV integrase strand transfer inhibitors in healthy subjects

A single dose study to evaluate the microdose pharmacokinetics of candidate HIV integrase strand transfer inhibitors in healthy subjects - Integrase Microdose Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42414

Enrollment

Registered

2015-04-21

Start date

2015-04-29

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

HIV-1

Interventions

The study will consist of 1 period during which the volunteer will receive either one of the three study drugs compounds once. The study drug will be given in the form of an intravenous injection.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male volunteers 18 - 45 yrs, inclusive BMI: 18.5-32 kg/m2, inclusive non-smoking

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
To obtain preliminary plasma pharmacokinetic data (including AUC0-, AUC0-last, Cmax, Tmax, apparent terminal t, Cl, Vd) of single intravenous microdoses of L-1, L-2, and L-3 in healthy subjects.	—

Secondary

Measure	Time frame
To evaluate the safety and tolerability of single intravenous microdoses of L-1, L-2, and L-3 in healthy subjects.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)