Clinical trial NCT02549040: Bioavailability of Doravirine (MK-1439) Experimental Nano Formulations in Healthy Adults (MK-1439-046)
Official title: A Rapid Pharmacokinetic Trial of the Bioavailability of Four MK-1439 Nano Formulations in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Immunodeficiency Virus-1 (HIV-1)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2015-09-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of MK-1439 Following a Single Administration of MK-1439
timeFrame: 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
measure: 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
timeFrame: 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
measure: Maximum Plasma Concentration (Cmax) of MK-1439 Following a Single Administration of MK-1439
timeFrame: 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
measure: Plasma Concentration of MK-1439 at 24 Hours Post-dose (C24hr) Following a Single Administration of MK-1439
timeFrame: Periods 1 to 5: 24 hours post-dose
measure: Number of Participants Who Experienced at Least One Adverse Event
timeFrame: Up to 16 days after last dose of study treatment (up to approximately 92 days)
measure: Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
timeFrame: Up to 4 days after last dose of study treatment (up to approximately 76 days)
Secondary outcomes:
measure: 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
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: