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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Human Immunodeficiency Virus-1 (HIV-1)

Treatments: Drug: Treatment A: Doravirine 100 mg film coated tablet; Drug: Treatment B: Doravirine 150 mg tablet (40% 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: Treatment C: Doravirine 150 mg tablet (30% drug loaded granule)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02549040

2015-002702-36 (EudraCT Number)

1439-046

MK-1439-046 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Doravirine fixed sequence treatment

Experimental group

Description:

After a minimum 10 hour overnight fast, participants received a single oral dose during each of 5 periods. During Period 1, participants received Treatment B: Doravirine Type 1 dose (150 mg tablet \[40% drug loaded granule\]). During Period 2, participants received Treatment A: Doravirine 100 mg film coated tablet. During Period 3, participants received Treatment C: Doravirine Type 2 dose (150 mg tablet \[30% drug loaded granule\]). During Period 4, participants received Treatment D: Doravirine Type 3 dose (150 mg tablet \[50% drug loaded granule\]. During Period 5, participants received Treatment E: Doravirine Type 4 dose (100 mg tablet \[30% drug loaded granule\]). Each period was separated by a 14 day washout.

Treatment:

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

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

Drug: Treatment A: Doravirine 100 mg film coated tablet

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

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