Clinical trial NCT03930264: Bioequivalence of Azathioprine Suspension 10 mg/mL (Jayempi) Versus Azathioprine Tablet 50mg (Imurek®)
Official title: A Single Centre, Two Period Crossover Study to Assess the Bioequivalence of an Oral Azathioprine Suspension 10 mg/mL (Jayempi™) Versus Oral Azathioprine Tablet 50mg (Imurek®) in at Least 30 Healthy Adult Subjects Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Therapeutic Equivalency
Lead sponsor: Nova Laboratories Limited
Sponsor class: INDUSTRY
Collaborators: name: Medicines Evaluation Unit Ltd
name: Syne Qua Non Limited
name: Alderley Analytical Ltd.
name: Black County Pathology Services
name: Diamond Pharma Services Regulatory Affairs Consultancy
name: Boyd Consultants
First posted: 2019-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: A single center, single dose, open-label, randomized, two period crossover study to assess the bioequivalence of an oral azathioprine suspension 10 mg/mL (Jayempi™) versus oral azathioprine tablet 50mg (Imurek®, Aspen Pharma Trading Limited, Dublin, Ireland.) in at least 30 healthy adult subjects under fasting conditions.

Detailed description: This will be a single-dose, open-label, randomised, two-period crossover study with orally administered 1 x 5mL (50 mg) of Jayempi™ Oral Suspension 10mg/mL versus oral azathioprine tablet 50mg (Imurek®, Aspen Pharma Trading Limited, Dublin, Ireland) on two separate occasions conducted under fasting conditions in healthy male and female subjects at a single study centre.

The study will comprise:

* Thiopurine methyltransferase (TPMT) testing;
* Screening period of maximum 28 days
* Two treatment periods (each of which will include a PK profile period of 12 hours) separated by a wash-out period of at least 3 calendar days (minimum number of days based on half-life of the analyte) and maximum of 14 calendar days between consecutive administrations of the IMP
* A post-study visit 7-10 days after the last dose of the last treatment period of the study.

Subjects will be randomly assigned to treatment sequence, prior to the first administration of IMP.

Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers.
* No significant medical history or conditions that may interfere with the study.
* Adequate contraception.

Exclusion Criteria:

* Volunteers who may be likely to have the inherited mutated NUDT15.
* Subjects with a deficient, low or intermediate TPMT enzyme activity.
* Disease that may interfere with the safety of the participant or the study outcome measures.
* Participants who want to procreate in the next 6 months.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 18 hours
measure: AUC0-t
timeFrame: 18 hours
measure: AUC0-∞
timeFrame: 18 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Nova Laboratories Limited
state: Leicestershire
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit Ltd Southmoor Road
Study officials:
affiliation: Medicines Evaluation Unit
name: Naimat Khan, MD
role: PRINCIPAL_INVESTIGATOR
References: