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)

NCT03032367 | Completed Early Phase 1

• 1 other identifier: TASK-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Bioequivalence of bedaquiline 4 x 100mg given to healthy adult males and females orally in tablet form compared to crushed form

  The bioequivalence evaluation will be based on primary PK parameters affecting the extent of absorption, i.e. the bioavailability.

  Two single treatment sequences, separated by a 14-day wash-out period

Study Arms (2)

Sequence 1

OTHER

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

Sequence 2

OTHER

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

Interventions

bedaquiline DRUG

Also known as: Sirturo

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Maternal Pediatric Adolescent AIDS Clinical Trials Group: lead
• US National Institute of Allergy and Infectious Diseases: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

TASK Clinical Research Centre

Bellville, Western Cape, 7530, South Africa

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

bedaquiline

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Jeannine du Bois, MD

  TASK Clinical Research Centre

  STUDY CHAIR

• Anthony Garcia-Pratts, MD

  Desmond Tutu TB Centre, Stellenbosch University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: January 26, 2017
• Study Start: November 10, 2016
• Primary Completion: December 9, 2016
• Study Completion: January 11, 2017
• Last Updated: July 28, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)