NCT01682538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 20, 2014

Completed
Last Updated

March 17, 2014

Status Verified

February 1, 2014

Enrollment Period

2 months

First QC Date

September 7, 2012

Results QC Date

October 8, 2013

Last Update Submit

February 20, 2014

Conditions

Healthy Volunteers

Keywords

OrfadinNitisinoneBioequivalenceBioavailability

Outcome Measures

Primary Outcomes (2)

  • The Area Under the Serum Concentration Curve (AUC) During 72 Hours After Dose (AUC72h) During Fasting Conditions.

    Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.

  • The Maximum Serum Concentration (Cmax) During Fasting Conditions.

    Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.

Secondary Outcomes (7)

  • The Area Under the Serum Concentration Curve (AUC) During 72 Hours After Dose (AUC72h)

    Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.

  • The Maximum Serum Concentration (Cmax)

    Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.

  • AUC From Time Zero to Infinity

    Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.

  • Time to Reach C-Max (t-Max)

    Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.

  • Terminal Half-life

    Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.

  • +2 more secondary outcomes

Study Arms (3)

Orfadin capsules, fasting

ACTIVE COMPARATOR

Orfadin capsules, single dose, 30 mg

Drug: Nitisinone, capsule

Orfadin suspension, fasting

EXPERIMENTAL

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

Drug: Nitisinone, suspension

Orfadin suspension, with food

EXPERIMENTAL

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

Drug: Nitisinone, suspension

Interventions

Nitisinone, capsuleDRUG
Orfadin capsules, fasting
Nitisinone, suspensionDRUG
Orfadin suspension, fastingOrfadin suspension, with food

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharmaceutical Research Associates Group B.V (PRA)

Zuidlaren, Netherlands

Location

MeSH Terms

Interventions

nitisinoneCapsulesSuspensions

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical PreparationsColloidsComplex Mixtures

Results Point of Contact

Title
Medical Director
Organization
Swedish Orphan Biovitrum
erik.brouwer@sobi.com
+4686972000

Study Officials

  • Erik Brouwer, MD

    Swedish Orphan Biovitrum

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2012

First Posted

September 11, 2012

Study Start

August 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

March 17, 2014

Results First Posted

February 20, 2014

Record last verified: 2014-02

Locations

NL(1)