FMI Food Effect Study of Doravirine/Islatravir (MK-8591A) in Healthy Japanese Participants

A Single-dose Clinical Study to Evaluate the Effect of Food on the Pharmacokinetics of Doravirine/Islatravir (MK-8591A) Final Market Image Formulation in Healthy Adult Japanese Participants.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031200365

Enrollment

Registered

2021-02-17

Start date

2021-02-17

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Healthy volunteer

Interventions

100 mg DOR/0.75 mg ISL FDC taken by mouth

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy male or female aged 20 to 45 years old with BMI 18.5 to 25.0 kg/m2

Exclusion criteria

Exclusion criteria: Has a history of clinically significant abnormalities or diseases.

Design outcomes

Primary

Measure	Time frame
AUC0-inf, AUC0-last, AUC0-24, Cmax, Tmax, apparent terminal t1/2, C24, CL/F and V/F for Doravirine and Islatravir	—

Contacts

Public ContactMSDJRCT inquiry mailbox

MSD K.K.

msdjrct@msd.com+81-3-6272-1957

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026