CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Treatment A: Doravirine 100 mg film coated tablet +4 moredrug
Likely dose
Treatment A: Doravirine 100 mg film coated tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02549040
NCT02549040Phase 1Completed
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A Rapid Pharmacokinetic Trial of the Bioavailability of Four MK-1439 Nano Formulations in Healthy Adults

Merck Sharp & Dohme LLC·interventional·Posted Sep 14, 2015·Updated Jan 7, 2021

In Brief

A Phase 1 clinical trial evaluating Treatment A: Doravirine 100 mg film coated tablet, Treatment B: Doravirine 150 mg tablet (40% drug loaded granule), and 3 other interventions for Human Immunodeficiency Virus-1 (HIV-1). Completed, enrolled 16 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Virus-1 (HIV-1)
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 14, 2015
Enrollment StartSep 21, 2015
Primary CompletionDec 24, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.8 years ago

Interventions

Treatment A: Doravirine 100 mg film coated tabletdrug

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

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

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

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

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