Phase 1
Completed N=16
Bioavailability of Doravirine (MK-1439) Experimental Nano Formulations in Healthy Adults (MK-1439-046)
Source: ClinicalTrials.gov NCT02549040 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of MK-1439 Following a Single Administration of MK-1439 — 28.6; 31.9; 35.5; 29.1 µM*h
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of MK-1439 Following a Single Administration of MK-1439 |
28.6; 31.9; 35.5; 29.1; 28.0 | — |
| PRIMARY 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 |
26.3; 29.9; 32.7; 27.0; 26.3 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of MK-1439 Following a Single Administration of MK-1439 |
1070; 1520; 1320; 1060; 1160 | — |
| PRIMARY Plasma Concentration of MK-1439 at 24 Hours Post-dose (C24hr) Following a Single Administration of MK-1439 |
395; 483; 508; 412; 402 | — |
| PRIMARY Number of Participants Who Experienced at Least One Adverse Event |
2; 5; 4; 6; 1 | — |
| PRIMARY Number of Participants Who Discontinued Study Treatment Due to an Adverse Event |
0; 0; 0; 0; 0 | — |
| SECONDARY 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 |
22.8; 27.2; 28.8; 23.2; 23.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT02549040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.