Bioequivalence of Orfadin Suspension Compared to Orfadin Capsules, and the Effect of Food on the Bioavailability of the Suspension

NCT ID: NCT01682538

Last Updated: 2014-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2012-10-31

Brief Summary

The study is primarily being performed in order to demonstrate bioequivalence between the Orfadin (nitisinone) suspension and the marketed capsule formulation. The study will also contain a comparison of the bioavailability of the suspension given with food and on an empty stomach.

Detailed Description

This is an open, randomized 3-way crossover study in 12 healthy volunteers. Subjects will receive single oral 30-mg doses of nitisinone as a suspension (fasting and with food) and as hard gelatin capsules (fasting only). There will be a 2-week washout period between the doses.

There will be a screening visit within 3 weeks prior to the first dose. During each treatment period, subjects will be admitted to the clinic from the afternoon on the day before drug administration (i.e., on Day -1) and remain at the clinic until the 48-hour post-dose blood sample has been collected in the morning of Day 3. They will then return for ambulatory visit in the morning of Day 4 (72-hour sample). A follow-up visit will take place 7-14 days after the last dose.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Orfadin capsules, fasting

Orfadin capsules, single dose, 30 mg

Group Type: ACTIVE_COMPARATOR

Nitisinone, capsule

Intervention Type: DRUG

Orfadin suspension, fasting

Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)

Group Type: EXPERIMENTAL

Nitisinone, suspension

Intervention Type: DRUG

Orfadin suspension, with food

Orfadin suspension 4mg/mL, single dose 30 mg (7,5 mL)

Group Type: EXPERIMENTAL

Nitisinone, suspension

Intervention Type: DRUG

Interventions

Nitisinone, capsule

Intervention Type: DRUG

Nitisinone, suspension

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male volunteers
• Age: 18-55 years, inclusive
• BMI: 18,5-30,0 kg/m2, inclusive

Exclusion Criteria

• heavy smokers
• Consumption of more than 4 cups of coffee per day.
• History of drug and/or alcohol abuse.
• Positive drug screen or alcohol breath test.
• Positive screens for hepatitis B surface antigen, hepatitis C antibodies and human immunodeficiency virus (HIV) 1-2 antibodies.
• Enrollment in another concurrent clinical study
• Intake of an investigational medicinal product within three months prior to inclusion in this study.
• Donation of more than 50 mL of blood within 60 days prior to drug administration
• Donation of more than 1,5 liters of blood in the 10 months prior to first drug administration.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik Brouwer, MD

Role: STUDY_DIRECTOR

Swedish Orphan Biovitrum

Locations

Pharmaceutical Research Associates Group B.V (PRA)

Zuidlaren, , Netherlands

Countries

Netherlands

Other Identifiers

Sobi.NTBC-001

Identifier Type: -

Identifier Source: org_study_id