Clinical trial NCT04087759: A Study of Bedaquiline 100 Milligram (mg) Tablets Administered as Different Test Formulations Compared to the Commercial Tablet Formulation (F001) in Healthy Adult Participants
Official title: Phase 1, Open-label, Randomized Crossover Study in Healthy Adult Subjects to Assess the Relative Oral Bioavailability and Food Effect of Bedaquiline 100-mg Tablets Administered as Different Test Formulations Compared to the Commercial Tablet Formulation (F001)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-09-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Observed Analyte Concentration (Cmax) of Bedaquiline
timeFrame: Predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, and 672 hours postdose
measure: Area Under the Analyte Concentration-time Curve from Time 0 to 72 Hours (AUC [0-72 hours]) of Bedaquiline
timeFrame: Predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
measure: Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC [0-last]) of Bedaquiline
timeFrame: Predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, and 672 hours postdose
measure: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of Bedaquiline
timeFrame: Predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, and 672 hours postdose
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Up to 112 Days
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: SGS Life Science Services
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: