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

NCT02549040 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-01-07

Study results available
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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.

Conditions

  • Human Immunodeficiency Virus-1 (HIV-1)

Interventions

DRUG

Treatment A: Doravirine 100 mg film coated tablet

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

DRUG

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

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

DRUG

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

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

DRUG

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

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

DRUG

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

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-21
Primary Completion
2015-12-24
Completion
2015-12-24

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02549040 on ClinicalTrials.gov