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

Human Immunodeficiency Virus-1 (HIV-1) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549040
• Other study ID #: 1439-046
• Secondary ID: 2015-002702-36MK
• Status: Completed
• Phase: Phase 1
• Start date: September 21, 2015
• Est. completion date: December 24, 2015

Study information

• Verified date: December 2020
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 24, 2015
• Est. primary completion date: December 24, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus-1 (HIV-1)

Intervention

Drug:
• Treatment A: Doravirine 100 mg film coated tablet
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)
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)
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)
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)
Single doravirine NF Type 4 dose (100 mg tablet [30% drug loaded granule]) administered orally at the start of Period 5

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of MK-1439 Following a Single Administration of MK-1439	During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose to determine AUC0-inf after a single administration of MK-1439.	Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose
Primary	Area Under the Plasma Concentration-time Curve From Time 0 to Last Time (AUC0-last) With Quantifiable MK-1439 Following a Single Administration of MK-1439	During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose to determine AUC0-last after a single administration of MK-1439.	Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose
Primary	Maximum Plasma Concentration (Cmax) of MK-1439 Following a Single Administration of MK-1439	During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose to determine Cmax after a single administration of MK-1439.	Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose
Primary	Plasma Concentration of MK-1439 at 24 Hours Post-dose (C24hr) Following a Single Administration of MK-1439	During each of the 5 treatment periods, blood samples were collected 24 hours after dosing to determine C24hr after a single administration of MK-1439.	Periods 1 to 5: 24 hours post-dose
Primary	Number of Participants Who Experienced at Least One Adverse Event	An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.	Up to 16 days after last dose of study treatment (up to approximately 92 days)
Primary	Number of Participants Who Discontinued Study Treatment Due to an Adverse Event	An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.	Up to 4 days after last dose of study treatment (up to approximately 76 days)
Secondary	Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours (AUC0-48 hr) Post-dose of MK-1439 Following a Single Administration of MK-1439	During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48 hours after dosing to determine AUC0-48hr after a single administration of MK-1439.	Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, and 48 hours post-dose