A Study of Bedaquiline 100 Milligram (mg) Tablets Administered as Different Test Formulations Compared to the Commercial Tablet Formulation (F001) in Healthy Adult Participants

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Bedaquiline (Reference formulation); Drug: Bedaquiline (Test formulation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04087759

2018-004306-26 (EudraCT Number)

CR108659

TMC207TBC1004 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the rate and extent of absorption of bedaquiline following administration of a single oral dose of 100 milligram (mg) equivalent (1*100 mg) given as different test tablet formulations compared to the administration of a single oral dose of 100 mg equivalent (1*100 mg) formulated as SIRTURO commercial tablet (formulation F001), under fasted conditions in healthy adult participants. Also, to assess the effect of a standardized breakfast on the rate and extent of absorption of bedaquiline compared to fasted conditions following administration of a single oral dose of 100 mg equivalent (1*100 mg) for each of the different test tablet formulations.

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A female participant must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1 in each treatment period
• Contraceptive use by women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
• Participant must have a blood pressure (BP); supine after at least 5 minutes rest) between 90 and 140 millimeter of mercury (mmHg) systolic, extremes included, and no higher than 90 mmHg diastolic at screening
• Participant must be healthy on the basis of physical examination, medical history, vital signs, and electrocardiogram (ECG) performed at screening (results must be available on Day -1). If there are abnormalities participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
• Participant must have a body mass index (BMI); weight per height square between 18.0 and 30.0 kilogram per meter square (kg/m^2) (extremes included) at screening. The minimum body weight must be 50.0 kg at screening

Exclusion criteria

• Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
• Participant has known allergies, hypersensitivity, or intolerance to bedaquiline or its excipients
• Participant has received an investigational drug or used an invasive investigational medical device within 30 days or within a period less than 10 times the drug's elimination half-life (whichever is longer), or participant has received a biological product within 3 months or within a period less than 5 elimination half-lives (whichever is longer) before the planned first intake of study drug
• Participant has a history of human immunodeficiency virus (HIV)-1 or HIV-2 infection, or tests positive for HIV-1 or -2 at screening
• Participant has previously been dosed with bedaquiline, either in single or multiple dose studies, or participant with a previous history of pulmonal infection with Mycobacterium species

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 6 patient groups

Treatment Sequence BAE

Experimental group

Description:

Participants will receive a single dose of bedaquiline in 3 subsequent sessions as bedaquiline oral test tablet 1 under fasted condition (Treatment B) in period 1, followed by bedaquiline oral reference tablet under fasted condition (Treatment A) in period 2, thereafter will receive bedaquiline oral test tablet 1 under fed condition (Treatment E) in period 3. Each treatment period will be separated with a washout period of at least 28 days.

Treatment:

Drug: Bedaquiline (Test formulation)

Drug: Bedaquiline (Reference formulation)

Treatment Sequence CAF

Experimental group

Description:

Participants will receive a single dose of bedaquiline in 3 subsequent sessions as bedaquiline oral test tablet 2 under fasted condition (Treatment C) in period 1, followed by bedaquiline oral reference tablet under fasted condition (Treatment A) in period 2, thereafter will receive bedaquiline oral test tablet II under fed condition (Treatment F) in period 3. Each treatment period will be separated with a washout period of at least 28 days.

Treatment:

Drug: Bedaquiline (Test formulation)

Drug: Bedaquiline (Reference formulation)

Treatment Sequence DAG

Experimental group

Description:

Participants will receive a single dose of bedaquiline in 3 subsequent sessions as bedaquiline oral test tablet 3 under fasted condition (Treatment D) in period 1, followed by bedaquiline oral reference tablet under fasted condition (Treatment A) in period 2, thereafter will receive bedaquiline oral test tablet 3 under fed condition (Treatment G) in period 3. Each treatment period will be separated with a washout period of at least 28 days.

Treatment:

Drug: Bedaquiline (Test formulation)

Drug: Bedaquiline (Reference formulation)

Treatment Sequence ABE

Experimental group

Description:

Participants will receive a single dose of bedaquiline in 3 subsequent sessions as bedaquiline oral reference tablet under fasted condition (Treatment A) in period 1, followed by bedaquiline oral test tablet 1 under fasted condition (Treatment B) in period 2, thereafter will receive bedaquiline oral test tablet 1 under fed condition (Treatment E) in period 3. Each treatment period will be separated with a washout period of at least 28 days.

Treatment:

Drug: Bedaquiline (Test formulation)

Drug: Bedaquiline (Reference formulation)

Treatment Sequence ACF

Experimental group

Description:

Participants will receive a single dose of bedaquiline in 3 subsequent sessions as bedaquiline oral reference tablet under fasted condition (Treatment A) in period 1, followed by bedaquiline oral test tablet 2 under fasted condition (Treatment C) in period 2, thereafter will receive bedaquiline oral test tablet 2 under fed condition (Treatment F) in period 3. Each treatment period will be separated with a washout period of at least 28 days.

Treatment:

Drug: Bedaquiline (Test formulation)

Drug: Bedaquiline (Reference formulation)

Treatment Sequence ADG

Experimental group

Description:

Participants will receive a single dose of bedaquiline in 3 subsequent sessions as bedaquiline oral reference tablet under fasted condition (Treatment A) in period 1, followed by bedaquiline oral test tablet 3 under fasted condition (Treatment D) in period 2, thereafter will receive bedaquiline oral test tablet 3 under fed condition (Treatment G) in period 3. Each treatment period will be separated with a washout period of at least 28 days.

Treatment:

Drug: Bedaquiline (Test formulation)

Drug: Bedaquiline (Reference formulation)