NCT03103568 - A Study to Investigate the Potential Influence of Nitisinone on the Metabolism and the Transport of Other Drugs in Healthy Volunteers | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 28, 2017

Primary Completion Date

June 10, 2017

Study Completion Date

July 24, 2017

Conditions

Drug Drug Interaction

Interventions

DRUG

Nitisinone in Arm A

4 capsules of 20 mg nitisinone (80 mg) is given once daily for 17 days.

DRUG

Tolbutamide

A 500 mg tablet is given as single oral dose 2 weeks apart.

DRUG

Metoprolol

A 50 mg tablet of metoprolol tartrate is given as single oral dose 2 weeks apart.

DRUG

Chlorzoxazone

A 250 mg tablet is given as single oral dose 2 weeks apart.

DRUG

Furosemide

A single intravenous dose of 20 mg administered as an i.v. infusion is given 2 weeks apart.

DRUG

Nitisinone in Arm B

4 capsules of 20 mg nitisinone (80 mg) is given once daily for 16 days.

Trial Locations (1)

PAREXEL EPCU Berlin, Berlin