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A Study to Investigate the Potential Influence of Nitisinone on the Metabolism and the Transport of Other Drugs in Healthy Volunteers

NCT03103568 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-08-10

No results posted yet for this study

Summary

An open-label, non-randomized, 2-arm, 2-period fixed sequence phase 1 study to evaluate the potential inhibition of nitisinone on cytochrome P450 2C9, 2D6, and 2E1 and the organic anion transporters OAT1 and OAT3 in healthy volunteers

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.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Swedish Orphan Biovitrum

    lead INDUSTRY

Principal Investigators

  • Anders Bröijersén, MD, PhD · Swedish Orphan Biovitrum

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-28
Primary Completion
2017-06-10
Completion
2017-07-24

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03103568 on ClinicalTrials.gov