TuberculosisEarly Phase 1NCT03032367
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)
A Early Phase 1 study testing bedaquiline in people with Tuberculosis, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- bedaquiline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Africa
- Study dates
- 10 Nov 2016to 11 Jan 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
- aspartate aminotransferase (AST) grade 3 (≥3.0 x ULN)
- alanine aminotransferase (ALT) grade 3 (≥3.0 x ULN)
Trial locations and contacts
1 site in 1 country.
South Africa1 site
TASK Clinical Research Centre
Bellville, Western Cape, 7530
About this study
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.
Read the 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.
- Conditions
- Tuberculosis
- Being tested
- bedaquiline
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bedaquilineDrug
Also called Sirturo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: bedaquiline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two single treatment sequences, separated by a 14-day wash-out period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start10 Nov 2016
- Primary completion9 Dec 2016
- Study completion11 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jeannine du Bois, MD, Study chair, TASK Clinical Research CentreAnthony Garcia-Pratts, MD, Study chair, Desmond Tutu TB Centre, Stellenbosch University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032367
- Sponsor's protocol ID
- TASK-002
- Status last verified
- Jul 2017
- First submitted
- 24 Jan 2017
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03032367
- Acronym / sponsor ID
- TASK-002
- Conditions
- Tuberculosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials GroupResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Study start
- 10 Nov 2016 (actual)
- Primary completion
- 9 Dec 2016 (actual)
- Study completion
- 11 Jan 2017 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Other | Drug: bedaquilineBedaquiline 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 |
| Sequence 2 | Other | Drug: bedaquilineBedaquiline 4x 100mg administered in crushed form, followed by bedaquiline 4 x 100mg administered in a whole tablet form, as a once only oral dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bedaquilineAlso: Sirturo | Drug | Sequence 1, Sequence 2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeannine du Bois, MD study chair
TASK Clinical Research Centre
Anthony Garcia-Pratts, MD study chair
Desmond Tutu TB Centre, Stellenbosch University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing bedaquiline in people with Tuberculosis, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.