A Study of Doravirine and Islatravir as a Single Entity or Combination Therapy and the Effect of Food in Healthy Adult Participants (MK-8591A-055)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: MK-8591A; Drug: Islatravir; Drug: Doravine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06719570

8591A-055

CA42943 (Other Identifier)

MK-8591A-055 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Inclusion Criteria include, but are not limited to:

• 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)

Exclusion criteria

Exclusion Criteria include, but are not limited to:

• 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 6 patient groups

MK-8591A Sequence 1A

Experimental group

Description:

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.

Treatment:

Drug: Doravine

Drug: Islatravir

Drug: MK-8591A

MK-8591A Sequence 2A

Experimental group

Description:

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.

Treatment:

Drug: Doravine

Drug: Islatravir

Drug: MK-8591A

MK-8591A Sequence 1B

Experimental group

Description:

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.

Treatment:

Drug: Doravine

Drug: Islatravir

Drug: MK-8591A

MK-8591A Sequence 2B

Experimental group

Description:

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.

Treatment:

Drug: Doravine

Drug: Islatravir

Drug: MK-8591A

MK-8591A Sequence 1C

Experimental group

Description:

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.

Treatment:

Drug: Doravine

Drug: Islatravir

Drug: MK-8591A

MK-8591A Sequence 2C

Experimental group

Description:

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.

Treatment:

Drug: Doravine

Drug: Islatravir

Drug: MK-8591A