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

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ClinicalTrials.gov Identifier: NCT02549040
Recruitment Status : Completed
First Posted : September 14, 2015
Results First Posted : February 22, 2019
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE September 11, 2015
First Posted Date  ICMJE September 14, 2015
Results First Submitted Date  ICMJE September 27, 2018
Results First Posted Date  ICMJE February 22, 2019
Last Update Posted Date January 7, 2021
Actual Study Start Date  ICMJE September 21, 2015
Actual Primary Completion Date December 24, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
  • Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of MK-1439 Following a Single Administration of MK-1439 [ Time Frame: 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 ]
    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.
  • 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 [ Time Frame: 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 ]
    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.
  • Maximum Plasma Concentration (Cmax) of MK-1439 Following a Single Administration of MK-1439 [ Time Frame: 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 ]
    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.
  • 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 ]
    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.
  • 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) ]
    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.
  • Number of Participants Who Discontinued Study Treatment Due to an Adverse Event [ Time Frame: Up to 4 days after last dose of study treatment (up to approximately 76 days) ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2015)
  • 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) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
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 [ Time Frame: 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 ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2015)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability of Doravirine (MK-1439) Experimental Nano Formulations in Healthy Adults (MK-1439-046)
Official Title  ICMJE A Rapid Pharmacokinetic Trial of the Bioavailability of Four MK-1439 Nano Formulations in Healthy Adults
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Human Immunodeficiency Virus-1 (HIV-1)
Intervention  ICMJE
  • Drug: Treatment A: Doravirine 100 mg film coated tablet
    Single doravirine 100 mg film coated tablet administered orally at the start of Period 2
    Other Name: MK-1439
  • 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
    Other Name: MK-1439
  • 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
    Other Name: MK-1439
  • 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
    Other Name: MK-1439
  • 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
    Other Name: MK-1439
Study Arms  ICMJE Experimental: 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.
Interventions:
  • Drug: Treatment A: Doravirine 100 mg film coated tablet
  • Drug: Treatment B: Doravirine 150 mg tablet (40% drug loaded granule)
  • Drug: Treatment C: Doravirine 150 mg tablet (30% 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2015)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 24, 2015
Actual Primary Completion Date December 24, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT02549040
Other Study ID Numbers  ICMJE 1439-046
2015-002702-36 ( EudraCT Number )
MK-1439-046 ( Other Identifier: Merck Protocol Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP