Conditions: Human Immunodeficiency Virus-1 (HIV-1)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 16
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: 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.

Interventions: intervention 1: Treatment A: Doravirine 100 mg film coated tablet intervention 2: Treatment B: Doravirine 150 mg tablet (40% drug loaded granule) intervention 3: Treatment C: Doravirine 150 mg tablet (30% drug loaded granule) intervention 4: Treatment D: Doravirine 150 mg tablet (50% drug loaded granule) intervention 5: Treatment E: Doravirine 100 mg tablet (30% drug loaded granule)
Intervention descriptions: intervention 1: Single doravirine 100 mg film coated tablet administered orally at the start of Period 2 intervention 2: Single doravirine NF Type 1 dose (150 mg tablet \[40% drug loaded granule\]) administered orally at the start of Period 1 intervention 3: Single doravirine NF Type 2 dose (150 mg tablet \[30% drug loaded granule\])administered orally at the start of Period 3 intervention 4: Single doravirine NF Type 3 dose (150 mg tablet \[50% drug loaded granule\])administered orally at the start of Period 4 intervention 5: Single doravirine NF Type 4 dose (100 mg tablet \[30% drug loaded granule\]) administered orally at the start of Period 5

Protocol document: