Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

TASK-002: Bioequivalence of Bedaquiline 400mg Administered in Crushed Form Compared to Tablet Form in Healthy Male and Female Adults Under Fed Conditions (BDQ Crush Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032367
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : July 28, 2017
Sponsor:
Collaborators:
US National Institute of Allergy and Infectious Diseases
US National Institute of Child Health and Human Development
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Brief Summary:
This is a randomized, open-label, cross-over study comparing the bioequivalence of bedaquiline administered in whole tablet form versus bedaquiline administered in crushed (experimental) form in healthy adult volunteers.

Condition or disease Intervention/treatment Phase
Tuberculosis Drug: bedaquiline Early Phase 1

Detailed Description:
This is a randomized, open-label, cross-over, bioequivalence study with two single treatment periods, separated by a 14-day wash-out period, conducted among 24 healthy adult males and females, who receive 400mg (4 x 100mg) bedaquiline orally in one of two sequences: either first in whole tablet form and second in crushed (experimental) form, or vice versa under fed conditions. The bioequivalence evaluation will be based on primary pharmacokinetic (pk) parameters affecting the extent of absorption, i.e., the bioavailability. If bioequivalence is not shown, the knowledge about the differences in bioavailability between whole and crushed tablets will be used for assessing the need of dose adjustment in children receiving the crushed form.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Participants are randomized to receive study drug (bedaquiline (BDQ)) in either tablet form or crushed form in one of two sequences:

Sequence 1: BDQ 4 x 100mg administered in a whole tablet form, followed by BDQ 4 x 100mg administered in crushed form as a once only dose

Sequence 2: BDQ 4 x 100mg administered in crushed form, followed by BDQ 4 x 100mg administered in tablet form as a once only dose

Masking: None (Open Label)
Primary Purpose: Other
Official Title: TASK-002: Bioequivalence of Bedaquiline 400mg Administered in Crushed Form Compared to Tablet Form in Healthy Male and Female Adults Under Fed Conditions (BDQ Crush Study)
Actual Study Start Date : November 10, 2016
Actual Primary Completion Date : December 9, 2016
Actual Study Completion Date : January 11, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sequence 1
Bedaquiline 4 x 100mg administered in a whole tablet form, followed by bedaquiline 4 x 100mg administered in crushed form as a once only oral dose
Drug: bedaquiline
Other Name: Sirturo

Sequence 2
Bedaquiline 4x 100mg administered in crushed form, followed by bedaquiline 4 x 100mg administered in a whole tablet form, as a once only oral dose
Drug: bedaquiline
Other Name: Sirturo




Primary Outcome Measures :
  1. Bioequivalence of bedaquiline 4 x 100mg given to healthy adult males and females orally in tablet form compared to crushed form [ Time Frame: Two single treatment sequences, separated by a 14-day wash-out period ]
    The bioequivalence evaluation will be based on primary PK parameters affecting the extent of absorption, i.e. the bioavailability.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Written informed consent, including HIV testing
  • Male or female between 18 and 55 years of age inclusive
  • Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive
  • In the opinion of the investigator, able to comply with the requirements of the protocol e.g. able to attend all visits for PK analysis
  • Be of non-childbearing potential or using effective methods of birth control

Exclusion Criteria:

  • Known or suspected hypersensitivity or intolerance to bedaquiline or any other constituents of the study drug, i.e. lactose
  • A history or clinical evidence of any clinically significant cardiac condition including but not limited to congenital long QT syndrome, Torsades de Pointes, bradyarrhythmias
  • Uncontrolled cardiac dysrhythmias
  • Severe hepatic impairment (Child Pugh C)
  • History, symptoms or signs of heart failure
  • History, symptoms or signs of hypothyroidism, whether currently controlled or uncontrolled
  • Any other serious uncontrolled medical condition or clinically significant abnormality, which, in the opinion of the investigator, might compromise the safety of the subject or which might interfere with the study.
  • Evidence of clinically significant (as judged by the investigator), metabolic, gastrointestinal, cardiovascular, musculoskeletal, ophthalmological, pulmonary, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities.
  • Concomitant use of medicines known to prolong the QTc interval, or use of CYP3A4 inducers/inhibitors including but not limited to, carbamazepine, phenytoin, St. John's wort, ciprofloxacin, erythromycin, clarithromycin, fluconazole, ketoconazole, ritonavir or other anti-retroviral medications, fluoroquinolones and clofazamine.
  • HIV positive, already known or as per HIV test done at screening.
  • Hepatitis B or C positive
  • QTc prolongation as per ECG with a QTcF of >450msec or any other significant finding on the ECG as per the investigator
  • Receipt of any study drug within the past 3 months.
  • Scheduled to receive any other investigational drug during the course of the study.
  • Known or suspected, current or history of within the past 2 years, alcohol or drug abuse, that is, in the opinion of the Investigator, sufficient to compromise the safety or cooperation of the volunteer.
  • Evidence or suspicion of active TB or documented recent (within the last year) household contact with an infectious TB case.
  • The following toxicities at screening as defined by the DAIDS toxicity table (November 2014)

    1. aspartate aminotransferase (AST) grade 3 (≥3.0 x ULN)
    2. alanine aminotransferase (ALT) grade 3 (≥3.0 x ULN)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032367


Locations
Layout table for location information
South Africa
TASK Clinical Research Centre
Bellville, Western Cape, South Africa, 7530
Sponsors and Collaborators
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
US National Institute of Allergy and Infectious Diseases
US National Institute of Child Health and Human Development
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Study Chair: Jeannine du Bois, MD TASK Clinical Research Centre
Study Chair: Anthony Garcia-Pratts, MD Desmond Tutu TB Centre, Stellenbosch University

Layout table for additonal information
Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT03032367     History of Changes
Other Study ID Numbers: TASK-002
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bedaquiline
Diarylquinolines
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents