A Study of Bedaquiline 100 Milligram (mg) Tablets Administered as Different Test Formulations Compared to the Commercial Tablet Formulation (F001) in Healthy Adult Participants
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT04087759
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment Sequence DAG Bedaquiline (Reference formulation) 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 Sequence BAE Bedaquiline (Test formulation) 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 Sequence ABE Bedaquiline (Test formulation) 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 Sequence CAF Bedaquiline (Reference formulation) 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 Sequence DAG Bedaquiline (Test formulation) 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 Sequence ACF Bedaquiline (Reference formulation) 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 Sequence BAE Bedaquiline (Reference formulation) 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 Sequence ACF Bedaquiline (Test formulation) 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 Sequence CAF Bedaquiline (Test formulation) 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 Sequence ABE Bedaquiline (Reference formulation) 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 Sequence ADG Bedaquiline (Test formulation) 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 Sequence ADG Bedaquiline (Reference formulation) 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.
- Primary Outcome Measures
Name Time Method Area Under the Analyte Concentration-time Curve from Time 0 to 72 Hours (AUC [0-72 hours]) of Bedaquiline Predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose AUC (0-72 hours) is area under the analyte concentration-time curve from time 0 to 72 hours, calculated by linear-linear trapezoidal summation.
Area Under the Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of Bedaquiline Predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, and 672 hours postdose AUC (0-infinity) is the area under the analyte concentration-time curve from time zero to infinity time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable concentration, and lambda(z) is apparent terminal elimination rate constant.
Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC [0-last]) of Bedaquiline Predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, and 672 hours postdose AUC (0-last) is area under the analyte concentration-time curve from time zero to the time of the last measurable (non-below quantification limit) concentration, calculated by linear-linear trapezoidal summation.
Maximum Observed Analyte Concentration (Cmax) of Bedaquiline Predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, and 672 hours postdose Cmax is the maximum observed analyte concentration.
- Secondary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability Up to 112 Days An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product does not necessarily have a causal relationship with the treatment. Therefore, it can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
Trial Locations
- Locations (1)
SGS Life Science Services
🇧🇪Antwerpen, Belgium