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

NCT ID: NCT02549040

Last Updated: 2021-01-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-21

Study Completion Date

2015-12-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Human Immunodeficiency Virus-1 (HIV-1)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Doravirine fixed sequence treatment

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.

Group Type EXPERIMENTAL

Treatment A: Doravirine 100 mg film coated tablet

Intervention Type DRUG

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)

Intervention Type DRUG

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)

Intervention Type DRUG

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)

Intervention Type DRUG

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)

Intervention Type DRUG

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

Interventions

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Treatment A: Doravirine 100 mg film coated tablet

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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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MK-1439 MK-1439 MK-1439 MK-1439 MK-1439

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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2015-002702-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-1439-046

Identifier Type: OTHER

Identifier Source: secondary_id

1439-046

Identifier Type: -

Identifier Source: org_study_id

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