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Trial registered on ANZCTR


Registration number
ACTRN12615000801516
Ethics application status
Approved
Date submitted
7/07/2015
Date registered
3/08/2015
Date last updated
6/07/2016
Type of registration
Prospectively registered

Titles & IDs
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
Secondary ID [1] 287051 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
idiopathic pulmonary fibrosis 295529 0
Condition category
Condition code
Respiratory 295804 295804 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 292274 0
Treatment: Drugs
Comparator / control treatment
Treatment C (200 mg of pirfenidone tablet) and Treatement D (267 mg pirfenidone capsule)
Control group
Active

Outcomes
Primary outcome [1] 295503 0
To determine the pharmacokinetic parameters (Cmax, AUCt, AUCinf, Tmax) of pirfenidone and compare them between all four treatment groups
Timepoint [1] 295503 0
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 [1] 315717 0
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).
Timepoint [1] 315717 0
Safety will be evaluated during each study period at Days 0, 7, 14 and 21 following study drug administration.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization will occur once participant eligibility is confirmed. Participants will be randomly assigned to one of the four possible study drug treatment sequences in a fashion that ensures: that each individual receives each treatment, that for each study period at least 32 participants are allocated to each treatment and that first-order carry-over effects are minimized. Each successive participant will receive a unique study identification number.
Allocation concealment is done by contacting the holder of the allocation schedule who is located at the central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization sequences
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
Pharmacokinetic parameters will be summarized using standard descriptive statistics, including means, medians, geometric means, ranges, inter-quartile ranges, standard deviations and standard errors.
Previous published pharmacokinetic data (Shi et.al 2007) related to pirfenidone indicate that the variability does not imply a large sample size to be employed for bioequivalence determination. Sample size calculation is based on the power of Schuirmann’s two one-sided tests procedure for interval hypotheses using the +/- 20 rule for the assessment of average bioequivalence.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/08/2015
Actual
6/08/2015
Date of last participant enrolment
Anticipated
1/09/2015
Actual
1/09/2015
Date of last data collection
Anticipated
Actual
30/09/2015
Sample size
Target
32
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 7023 0
Jordan
State/province [1] 7023 0

Funding & Sponsors
Funding source category [1] 291607 0
Commercial sector/Industry
Name [1] 291607 0
AFT Pharmaceuticals Ltd.
Country [1] 291607 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
AFT Pharmaceuticals Ltd.
Address
Level 1, 129 Hurstmere Rd, Takapuna, 0622, Auckland, NZ
Country
New Zealand
Secondary sponsor category [1] 290279 0
None
Name [1] 290279 0
Address [1] 290279 0
Country [1] 290279 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293142 0
International Pharmaceutical Research Centre
Ethics committee address [1] 293142 0
Ethics committee country [1] 293142 0
Jordan
Date submitted for ethics approval [1] 293142 0
30/12/2014
Approval date [1] 293142 0
20/01/2015
Ethics approval number [1] 293142 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58642 0
Dr Abdullah Hiyari
Address 58642 0
IPRC- Sport City Circle, Amman, Jordan
P.O Box: 963166 Amman 11196,Jordan
Country 58642 0
Jordan
Phone 58642 0
+962-6-562764
Fax 58642 0
Email 58642 0
iprc@iprc.com.jo
Contact person for public queries
Name 58643 0
Hartley Atkinson
Address 58643 0
AFT Pharmaceuticals Ltd.
Level 1, 129 Hurstmere Rd, Takapuna 0622, Auckland
Country 58643 0
New Zealand
Phone 58643 0
+64 9 488 0232
Fax 58643 0
Email 58643 0
hartley@aftpharm.com
Contact person for scientific queries
Name 58644 0
Hartley Atkinson
Address 58644 0
AFT Pharmaceuticals Ltd.
Level 1, 129 Hurstmere Rd, Takapuna 0622, Auckland
Country 58644 0
New Zealand
Phone 58644 0
+64 9 488 0232
Fax 58644 0
Email 58644 0
hartley@aftpharm.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.