Who is sponsoring NCT02372383?

NCT02372383 is sponsored by University of Colorado, Denver.

What condition does NCT02372383 study?

NCT02372383 studies Cystic Fibrosis.

What drugs are being tested in NCT02372383?

Interventions: Ethambutol, Rifampin, Azithromycin, Pancrelipase.

What is the status of NCT02372383?

NCT02372383 is currently COMPLETED.

Last reviewed 2021-01-20 · How we verify

Pharmacokinetic Evaluation of Nontuberculous Mycobacterial Antibiotics in Cystic Fibrosis Versus Controls

NCT02372383 NA COMPLETED Results posted

The purpose of this study is to determine antimycobacterial drug pharmacokinetics (PK) and pharmacodynamics (PD) in patients with cystic fibrosis (CF) to improve treatment of nontuberculous mycobacterial (NTM) lung disease.

Details

Lead sponsor	University of Colorado, Denver
Phase	NA
Status	COMPLETED
Enrolment	31
Start date	2014-10
Completion	2016-06

Conditions

Cystic Fibrosis

Interventions

Ethambutol
Rifampin
Azithromycin
Pancrelipase

Primary outcomes

Median Maximal Drug Concentration (Cmax) — 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose
Cmax of the oral antimycobacterial drugs (azithromycin, rifampin and ethambutol) under both fasting conditions and when taken with food plus supplemental pancreatic enzymes in subjects with pancreatic insufficient CF, compared to healthy controls.

Countries

United States