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OpenTrials
Completed

NCT Number: NCT06719570

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)

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.

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MK-8591A

Drug

Fixed dose combination tablet

Other names: Doravirine/Islatravir (DOR/ISL) Fixed-Dose Combination (FDC)

Islatravir

Drug

Oral capsule

Other names: MK-8591, ISL

Doravine

Drug

Oral tablet

Other names: MK-1439, DOR

Primary outcomes

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

    Time frame: At designated time points up to ~30 days

    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.

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

    Time frame: At designated time points up to ~30 days

    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.

  3. Maximum plasma concentration (Cmax) of doravine

    Time frame: At designated time points up to ~30 days

    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.

  4. Plasma concentration at 24 hours postdose (C24) of DOR

    Time frame: At designated time points up to ~24 hours postdose

    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.

  5. AUC0-inf of ISL

    Time frame: At designated time points up to ~30 days

    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.

  6. AUC0-last of ISL

    Time frame: At designated time points up to ~30 days

    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.

  7. Cmax of ISL

    Time frame: At designated time points up to ~30 days

    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.

Secondary outcomes

  1. Number of participants who experienced an adverse event (AE)

    Time frame: Up to ~44 days

    An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The number of participants with an adverse event will be reported.

  2. Number of participants who discontinued study intervention due to an AE

    Time frame: Up to ~30 days

    An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The number of participants who discontinue study intervention due to an AE will be reported.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label Study to Evaluate the Effect of a High-Fat Meal on the Pharmacokinetics of Doravirine/Islatravir (100 mg/0.25 mg) Fixed-dose Combination Tablet and to Compare the Pharmacokinetics of Doravirine/Islatravir to Doravirine and Islatravir Single Entities in Healthy Adult Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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