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Completed

NCT Number: 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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SGS Life Science Services

Antwerp, 2060, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bedaquiline (Test formulation)

Drug

Participants will receive bedaquiline orally.

Other names: JNJ-16175328

Bedaquiline (Reference formulation)

Drug

Participants will receive bedaquiline orally.

Other names: SIRTURO, TMC207

Primary outcomes

  1. Maximum Observed Analyte Concentration (Cmax) of Bedaquiline

    Time frame: 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.

  2. Area Under the Analyte Concentration-time Curve from Time 0 to 72 Hours (AUC [0-72 hours]) of Bedaquiline

    Time frame: 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.

  3. Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC [0-last]) of Bedaquiline

    Time frame: 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.

  4. Area Under the Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of Bedaquiline

    Time frame: 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.

Secondary outcomes

  1. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 12, 2019
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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