NCT06719570

Brief Summary

The purpose of this study is to learn what happens to MK-8591A in a person's body over time. Researchers will compare what happens to MK-8591A in the body when it is given with and without food.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jan 2024

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
Last Updated

December 6, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

December 2, 2024

Last Update Submit

December 2, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

  • Area under the curve from time 0-infinity (AUC0-inf) of DOR

    AUC0-inf is a measure of plasma drug concentration from time 0 to infinity and is estimated as the area under the plot of plasma concentration against time 0 to infinity after drug administration. Blood samples collected at designated time points will be used to determine the AUC0-inf of DOR.

    At designated time points up to ~30 days

  • Area under the curve from time 0 to last measurable concentration (AUC0-last) of Doravine

    AUC0-last is defined as the area under the concentration-time curve from time 0 to time of last measurable concentration of DOR. Blood will be collected at designated time points to determine the AUC0-last of DOR.

    At designated time points up to ~30 days

  • Maximum plasma concentration (Cmax) of doravine

    Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected at designated time points will be used to determine Cmax of DOR.

    At designated time points up to ~30 days

  • Plasma concentration at 24 hours postdose (C24) of DOR

    C24 is the concentration at 24 hours postdose of the drug observed in plasma. Blood samples collected at 24 postdose will be used to determine C24 of DOR.

    At designated time points up to ~24 hours postdose

  • AUC0-inf of ISL

    AUC0-inf is a measure of plasma drug concentration and time 0 to infinity and is estimated as the area under the plot of plasma concentration against time 0 to infinity after drug administration. Blood samples collected at designated time points will be used to determine the AUC0-inf of ISL.

    At designated time points up to ~30 days

  • AUC0-last of ISL

    AUC0-last is defined as the area under the concentration-time curve from time zero to time of last measurable concentration of ISL. Blood will be collected at designated time points to determine the AUC0-last of ISL.

    At designated time points up to ~30 days

  • Cmax of ISL

    Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected at designated time points will be used to determine Cmax of ISL.

    At designated time points up to ~30 days

Secondary Outcomes (2)

  • Number of participants who experienced an adverse event (AE)

    Up to ~44 days

  • Number of participants who discontinued study intervention due to an AE

    Up to ~30 days

Study Arms (6)

MK-8591A Sequence 1A

EXPERIMENTAL

Participants will receive Doravine/Islatravir (DOR/ISL) fixed-dose combination (FDC) tablet under fasting conditions followed by a DOR/ISL FDC tablet under fed conditions followed by a single dose Doravine tablet and a single dose Islatravir capsule under fasting conditions.

Drug: MK-8591ADrug: IslatravirDrug: Doravine

MK-8591A Sequence 2A

EXPERIMENTAL

Participants will receive DOR/ISL FDC tablet under fasting conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fed conditions.

Drug: MK-8591ADrug: IslatravirDrug: Doravine

MK-8591A Sequence 1B

EXPERIMENTAL

Participants will receive DOR/ISL FDC tablet under fed conditions followed by a DOR/ISL FDC tablet under fasting conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting conditions.

Drug: MK-8591ADrug: IslatravirDrug: Doravine

MK-8591A Sequence 2B

EXPERIMENTAL

Participants will receive DOR/ISL FDC tablet under fed conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting condition followed by a DOR/ISL FDC tablet under fasting conditions.

Drug: MK-8591ADrug: IslatravirDrug: Doravine

MK-8591A Sequence 1C

EXPERIMENTAL

Participants will receive a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fasting conditions followed by followed by a DOR/ISL FDC tablet under fed conditions.

Drug: MK-8591ADrug: IslatravirDrug: Doravine

MK-8591A Sequence 2C

EXPERIMENTAL

Participants will receive a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fed conditions followed by followed by a DOR/ISL FDC tablet under fasting conditions.

Drug: MK-8591ADrug: IslatravirDrug: Doravine

Interventions

MK-8591ADRUG

Fixed dose combination tablet

Also known as: Doravirine/Islatravir (DOR/ISL) Fixed-Dose Combination (FDC)
MK-8591A Sequence 1AMK-8591A Sequence 1BMK-8591A Sequence 1CMK-8591A Sequence 2AMK-8591A Sequence 2BMK-8591A Sequence 2C
IslatravirDRUG

Oral capsule

Also known as: MK-8591, ISL
MK-8591A Sequence 1AMK-8591A Sequence 1BMK-8591A Sequence 1CMK-8591A Sequence 2AMK-8591A Sequence 2BMK-8591A Sequence 2C
DoravineDRUG

Oral tablet

Also known as: MK-1439, DOR
MK-8591A Sequence 1AMK-8591A Sequence 1BMK-8591A Sequence 1CMK-8591A Sequence 2AMK-8591A Sequence 2BMK-8591A Sequence 2C

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Has a body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\^2
  • Is medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and electrocardiograms (ECGs)

You may not qualify if:

  • Has a history or presence of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
  • Has a history of cancer (malignancy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Location

Related Links

MeSH Terms

Interventions

doravirineislatravir

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2024

First Posted

December 6, 2024

Study Start

January 23, 2024

Primary Completion

March 15, 2024

Study Completion

March 15, 2024

Last Updated

December 6, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

More information

Locations

US(1)