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OpenTrials
Completed

NCT Number: NCT02549040

Bioavailability of Doravirine (MK-1439) Experimental Nano Formulations in Healthy Adults (MK-1439-046)

This study aims to evaluate and compare the relative bioavailability of different doravirine (MK-1439) experimental nano formulations (NFs) with that of a doravirine film coated tablet.

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Key information

Conditions

Human Immunodeficiency Virus-1 (HIV-1)

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy participants
  • have been a non-smoker and/or have not used nicotine or nicotine-containing products for at least approximately 3 months

Exclusion criteria

  • is a pregnant or a nursing female
  • has a history of stroke, chronic seizures or major neurological disorder
  • has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
  • has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease

Treatment and study plan

Treatment A: Doravirine 100 mg film coated tablet

Drug

Single doravirine 100 mg film coated tablet administered orally at the start of Period 2

Other names: MK-1439

Treatment B: Doravirine 150 mg tablet (40% drug loaded granule)

Drug

Single doravirine NF Type 1 dose (150 mg tablet [40% drug loaded granule]) administered orally at the start of Period 1

Other names: MK-1439

Treatment C: Doravirine 150 mg tablet (30% drug loaded granule)

Drug

Single doravirine NF Type 2 dose (150 mg tablet [30% drug loaded granule])administered orally at the start of Period 3

Other names: MK-1439

Treatment D: Doravirine 150 mg tablet (50% drug loaded granule)

Drug

Single doravirine NF Type 3 dose (150 mg tablet [50% drug loaded granule])administered orally at the start of Period 4

Other names: MK-1439

Treatment E: Doravirine 100 mg tablet (30% drug loaded granule)

Drug

Single doravirine NF Type 4 dose (100 mg tablet [30% drug loaded granule]) administered orally at the start of Period 5

Other names: MK-1439

Primary outcomes

  1. Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of MK-1439 Following a Single Administration of MK-1439

    Time frame: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose

    During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose to determine AUC0-inf after a single administration of MK-1439.

  2. Area Under the Plasma Concentration-time Curve From Time 0 to Last Time (AUC0-last) With Quantifiable MK-1439 Following a Single Administration of MK-1439

    Time frame: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose

    During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose to determine AUC0-last after a single administration of MK-1439.

  3. Maximum Plasma Concentration (Cmax) of MK-1439 Following a Single Administration of MK-1439

    Time frame: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose

    During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose to determine Cmax after a single administration of MK-1439.

  4. Plasma Concentration of MK-1439 at 24 Hours Post-dose (C24hr) Following a Single Administration of MK-1439

    Time frame: Periods 1 to 5: 24 hours post-dose

    During each of the 5 treatment periods, blood samples were collected 24 hours after dosing to determine C24hr after a single administration of MK-1439.

  5. Number of Participants Who Experienced at Least One Adverse Event

    Time frame: Up to 16 days after last dose of study treatment (up to approximately 92 days)

    An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.

  6. Number of Participants Who Discontinued Study Treatment Due to an Adverse Event

    Time frame: Up to 4 days after last dose of study treatment (up to approximately 76 days)

    An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.

Secondary outcomes

  1. Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours (AUC0-48 hr) Post-dose of MK-1439 Following a Single Administration of MK-1439

    Time frame: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, and 48 hours post-dose

    During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48 hours after dosing to determine AUC0-48hr after a single administration of MK-1439.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Rapid Pharmacokinetic Trial of the Bioavailability of Four MK-1439 Nano Formulations in Healthy Adults

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 14, 2015
Registry last updated
Jan 7, 2021

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.