Phenotyping of High Dose Rifampicin

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

January 7, 2021

Primary Completion Date

August 12, 2021

Study Completion Date

August 12, 2021

Conditions
Tuberculosis
Interventions
COMBINATION_PRODUCT

phenotyping cocktail

A single dose of a cocktail of phenotyping probe drugs (caffeine, tolbutamide, omeprazole, dextromethorphan, midazolam and digoxin) will be administered together with standard dose rifampicin and 40 mg/kg rifampicin, respectively. Blood samples will be taken to assess phenotyping metrics of the cocktail agents and rifampicin pharmacokinetic parameters. The effect of high and standard dose rifampicin on the phenotyping metrics of the cocktail agents will be compared by using the bioequivalence approach

DRUG

rifampicin

A single dose of a cocktail of phenotyping probe drugs (caffeine, tolbutamide, omeprazole, dextromethorphan, midazolam and digoxin) will be administered together with standard dose rifampicin and 40 mg/kg rifampicin, respectively. Blood samples will be taken to assess phenotyping metrics of the cocktail agents and rifampicin pharmacokinetic parameters. The effect of high and standard dose rifampicin on the phenotyping metrics of the cocktail agents will be compared by using the bioequivalence approach

Trial Locations (2)

Unknown

TASK, Cape Town

UCT lung institute, Cape Town

All Listed Sponsors
lead

Radboud University Medical Center

OTHER

NCT04525235 - Phenotyping of High Dose Rifampicin | Biotech Hunter | Biotech Hunter