A study to evaluate the relative bioavailability and effect of food on two 450mg MK-3682 Fixed-Dose Combination Formulations (MK-3682 /MK-5172 /MK-8408)

A study to evaluate the relative bioavailability and effect of food on two 450mg MK-3682 Fixed-Dose Combination Formulations (MK-3682 /MK-5172 /MK-8408) - MK-3682-020

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41967

Enrollment

Registered

2015-01-07

Start date

2015-01-28

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

Hepatitis C

Interventions

The study will start with a screening visit. During the screening visit standard medical assessments including safety laboratory tests (blood draw, urine collection), an alcohol breath test, urine d

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Be willing to give written informed consent, including for Future Biomedical Research. 2. Be male or female, 18 to 55 years of age (inclusive) at the pretrial (screening) visit. 3. Standard liver function tests including ALT, AST, alkaline phosphatase and bilirubin (total and direct) do not exceed the upper limit of normal for the local laboratory at Screening and Day -1 of Period 1.

Exclusion criteria

Exclusion criteria: 1. A history of liver disease (exception: subjects with remote hepatitis A virus infection with full recovery can be included). 2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV). 3. A history of cancer (malignancy).

Design outcomes

Primary

Measure	Time frame
The pharmacokinetic (PK) parameters (AUC0-t, AUC0-, Cmax, C24, Tmax, and apparent t1/2) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8408 following administration of the fixed-dose combinations relative to the individual components when co-administered will be estimated. The effects of a high fat meal on the pharmacokinetic (PK) parameters (AUC0-t, AUC0-, Cmax, C24, Tmax, and apparent t1/2) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8408 following administration of the fixed-dose combinations relative to the fasted state will be estimated.	—

Measure

Time frame

The pharmacokinetic (PK) parameters (AUC0-t, AUC0-*, Cmax, C24, Tmax, and apparent t1/2) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8408 following administration of the fixed-dose combinations relative to the individual components when co-administered will be estimated. The effects of a high fat meal on the pharmacokinetic (PK) parameters (AUC0-t, AUC0-*, Cmax, C24, Tmax, and apparent t1/2) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8408 following administration of the fixed-dose combinations relative to the fasted state will be estimated.

—

Secondary

Measure	Time frame
Safety and tolerability	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)