Randomized, single dose, four period, cross-over open-label study to evaluate the pharmacokinetic parameters of 200 mg pirfenidone capsule versus pure pirfenidone 200 mg capsule (excluding excipients) versus 200 mg pirfenidone tablet versus 267 mg pirfenidone capsule in 32 healthy adults under fasting conditions

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000801516
• Date of registration: 03/08/2015
• Prospective Registration: Yes
• Primary sponsor: AFT Pharmaceuticals Ltd.
• Public title: Randomized, single dose, four period, cross-over open-label study to evaluate the pharmacokinetic parameters of 200 mg pirfenidone capsule versus pure pirfenidone 200 mg capsule (excluding excipients) versus 200 mg pirfenidone tablet versus 267 mg pirfenidone capsule in 32 healthy adults under fasting conditions
• Scientific title: Randomized, single dose, four period, cross-over open-label study to evaluate the pharmacokinetic parameters of 200 mg pirfenidone capsule versus pure pirfenidone 200 mg capsule (excluding excipients) versus 200 mg pirfenidone tablet versus 267 mg pirfenidone capsule in 32 healthy adults under fasting conditions
• Date of first enrolment: 06/08/2015
• Target sample size: 32
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000801516.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Pharmacokinetics;
• Phase: Phase 1

Countries of recruitment

Jordan

Contacts

• Name: Dr Hartley Atkinson

• Name: Dr Hartley Atkinson

Key inclusion & exclusion criteria

Inclusion criteria: Healthy subjects, males and females aged 18 to 50 years of age. Females must be sterile or using adequate contraception. Participants must not have taken any prescription medications for at least 14 days or over-the-counter medications for at least 7 days before the start of each study phase, with the exception of oral contraceptives and the study medication.
All subjects must be deemed healthy on the basis of a medical history, physical exam (including vital signs and ECG recording), urinalysis, and blood biochemical and haematological examinations.

Exclusion criteria: 1.Women who are pregnant or nursing.
2. Women of childbearing potential who are unwilling to take adequate contraceptive precautions, i.e., a hormonal contraceptive, an intrauterine device, double-barrier method, or abstinence. A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a partial or total hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral oophorectomy.
3. Women of childbearing potential who are unwilling to undergo a urine pregnancy test.
4. Have an alcohol intake in excess of 14 units per week for females and 21 units per week for males.
5. Have a history of drug abuse or positive test results for drug abuse during screening.
6. Unwilling to abstain from smoking throughout the whole duration of the study
7. Unable and refuse to abstain the used prescription drugs (not including oral contraceptives) within 14 days prior to study drug administration or have used over-the-counter drugs or herbal products within 7 days prior to study drug administration.


Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

idiopathic pulmonary fibrosis;
idiopathic pulmonary fibrosis

Respiratory - Other respiratory disorders / diseases

Intervention(s)

32 healthy participants will be randomly allocated, in a four-way cross-over fashion, to receive a single dose of the following oral treatments:
Treatment A: one capsule containing 200 mg pirfenidone
Treatment B: one capsule containing 200 mg pirfenidone without excipients (pure pirfenidone)
Treatment C: one tablet containing 200 mg pirfenidone
Treatment D: one capsule containing 267 mg pirfenidone
Each treatment will be administered orally with 240 ml of water.
There will be a washout period of 7 days between all treatments
Participants will be required to fast overnight (for at least 10 hours) before dosing and for 4 hours thereafter.

Primary Outcome(s)

To determine the pharmacokinetic parameters (Cmax, AUCt, AUCinf, Tmax) of pirfenidone and compare them between all four treatment groups[Plasma time concentrations will be determined from the blood samples collected at 10, 20, 30, 45 minutes and 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours after study drug administration. ]

Secondary Outcome(s)

To monitor and compare the safety and tolerability of pirfenidone amongst the different treatment groups. This is a composite secondary outcome.
The safety evaluation will consist of recording spontaneously reported adverse events and by measurements of vital signs (blood pressure, heart rate, respiratory rate, and temperature).[Safety will be evaluated during each study period at Days 0, 7, 14 and 21 following study drug administration. ]

Secondary ID(s)

Nil

Source(s) of Monetary Support

AFT Pharmaceuticals Ltd.

Ethics review

Status: Approved
Approval date:
Contact:

International Pharmaceutical Research Centre