Conditions: Hereditary Tyrosinemia, Type I
Keywords: HT-1 Tyrosinemia Nitisinone Bioavailability Healthy Volunteer Food-Effect
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 20
Healthy volunteers: yes

Brief summary:
The purpose of this study is to compare the bioavailability of the Test Product, Nitisinone 10 mg Tablet, under fasting and fed conditions (food-effect).

Detailed description:
The specific aim is to conduct a randomized, single dose, two-period crossover bioavailability study in at least 16 healthy male and female subjects at a single study center to evaluate the in vivo performance of Test Product, Nitisinone 10 mg Tablet, under fasting and fed conditions.

The study in healthy male and female volunteers is designed to establish a pharmacokinetic (PK) profile under fed and fasting conditions for the orally administered Test Product, Nitisinone 10 mg Tablets.

A total of 20 healthy female and male volunteers (age 18 to 55 years old) will be entered into the study. Volunteers will be determined to be free of significant medical conditions as assessed by medical history, physical examination, and blood and urine tests. Volunteers will be randomly allocated to receive the Test Product under fasting or fed conditions.

There will be a minimum 23 calendar days washout between treatments. Blood samples will be collected at pre-dose (0 hours) and at 15 minutes, 30 minutes, 1 hour, 2 hours, 2 hours and 30 minutes, 3 hours, 3 hours and 30 minutes, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours and 120 hours post-dose (total: 21 samples per treatment period).

Arms:
arm 1: Subjects will receive a single 10 mg tablet of Nitisinone in treatment period 1 under fed conditions, and 10 mg tablet of Nitisinone in treatment period 2 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period. arm 2: Subjects will receive a single 10 mg tablet of Nitisinone in treatment period 1 under fasting conditions, and 10 mg tablet of Nitisinone in treatment period 2 under fed conditions. Each treatment period will be separated by at least 23 calendar days of washout period.

Interventions: intervention 1: Nitisinone
Intervention descriptions: intervention 1: A single oral dose of Nitisinone 10 mg Tablet will be administered.

Protocol document: