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Bioavailability of Doravirine (MK-1439) Experimental Nano Formulations in Healthy Adults (MK-1439-046) | Clinical Trials | Clareo Health

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

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

NCT02549040•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

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

Key Dates

Start Date

September 21, 2015

Primary Completion Date

December 24, 2015

Completion Date

December 24, 2015

Last Updated

January 7, 2021

Enrollment

ACTUAL participants

Conditions

Human Immunodeficiency Virus-1 (HIV-1)

Interventions

Treatment A: Doravirine 100 mg film coated tablet

DRUG

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

DRUG

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

DRUG

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

DRUG

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

DRUG