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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02549040
First received: September 11, 2015
Last updated: February 4, 2016
Last verified: February 2016
  Purpose
This study aims to evaluate and compare the relative bioavailability of different MK-1439 experimental nano formulations (NFs) with that of a MK-1439 film coated tablet.

Condition Intervention Phase
Human Immunodeficiency Virus-1 (HIV-1) Drug: MK-1439 film coated tablet Drug: MK-1439 NF Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Rapid Pharmacokinetic Trial of the Bioavailability of Four MK-1439 Nano Formulations in Healthy Adults

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf) of MK-1439 following a single administration of MK-1439 [ Time Frame: Periods 1 to 5 at the following Day 1 time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose ]
  • Area under the plasma concentration-time curve from time 0 to last time (AUC 0-last) with quantifiable MK-1439 following a single administration of MK-1439 [ Time Frame: Periods 1 to 5 at the following Day 1 time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose ]
  • Maximum plasma concentration (Cmax) of MK-1439 following a single administration of MK-1439 [ Time Frame: Periods 1 to 5 at the following Day 1 time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose ]
  • Plasma concentration of MK-1439 at 24 hours post-dose (C24hr) following a single administration of MK-1439 [ Time Frame: Periods 1 to 5: 24 hours post-dose ]
  • Number of participants who experienced at least one adverse event [ Time Frame: Up to 16 days after last dose of study treatment (up to approximately 92 days) ]
  • Number of participants who discontinued study due to an adverse event [ Time Frame: Up to 4 days after last dose of study treatment (up to approximately 76 days) ]

Secondary Outcome Measures:
  • Area under the plasma concentration-time curve from time 0 to 48 hours (AUC 0-48 hr.) post-dose of MK-1439 following a single administration of MK-1439 [ Time Frame: Periods 1 to 5 at the following Day 1 time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, and 48 hours post-dose ]

Enrollment: 16
Study Start Date: September 2015
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-1439 fixed sequence treatment
After a minimum 10 hour overnight fast, participants are treated with a single oral dose of MK-1439 over a 5 Period fixed sequence. Each period is separated by a 14 day washout.
Drug: MK-1439 film coated tablet
A single MK-1439 film coated tablet, administered orally at the start of Period 2
Drug: MK-1439 NF
A single MK-1439 NF, administered orally at the start of Periods 1, 3, 4, and 5.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02549040

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02549040     History of Changes
Other Study ID Numbers: 1439-046
2015-002702-36 ( EudraCT Number )
Study First Received: September 11, 2015
Last Updated: February 4, 2016

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 19, 2017