SGS Life Science Services
Antwerp, 2060, Belgium
NCT Number: NCT03800550
The purpose of this study is to assess the effect of steady-state clarithromycin once every 12 hour on the pharmacokinetic parameters of bedaquiline and its active metabolite M2 after a single dose of bedaquiline.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Antwerp, 2060, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bedaquiline tablet will be administered, orally.
Clarithromycin tablet will be administered, orally.
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, and 240 hours Post-dose
Cmax is the maximum observed analyte concentration.
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, and 240 hours Post-dose
Cmin is the minimum observed analyte concentration.
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, and 72 hours Post-dose
AUC72h is the area under the analyte concentration versus time curve (AUC) from time of administration up to 72 hours post dosing, calculated by linear-linear trapezoidal summation.
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, and 240 hours Post-dose
AUC240h is the area under the analyte concentration-time curve from time 0 to 240 hours, calculated by linear-linear trapezoidal summation.
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, and 12 hours Post-dose
Cmax is the maximum observed analyte concentration.
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, and 12 hours Post-dose
Tmax is the actual sampling time to reach the maximum observed analyte concentration.
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, and 12 hours Post-dose
Cmin is the minimum observed analyte concentration.
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, and 12 hours Post-dose
AUC12h is the area under the analyte concentration versus time curve (AUC) from time of administration up to 12 hours post dosing, calculated by linear-linear trapezoidal summation.
Time frame: Up to 90 days
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Janssen Research & Development, LLC
Industry
A Phase 1, Open-label, Randomized, Crossover Study to Assess the Drug-Drug Interaction Between Bedaquiline and Clarithromycin in Healthy Adult Volunteers
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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