Bioequivalence of An Oral Mercaptopurine Suspension 100 Mg / 5 Ml Versus Tablet in Healthy Male Subjects Under Fasting Conditions

NCT ID: NCT01697020

Last Updated: 2013-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2012-11-30

Brief Summary

The primary objective of this study is to determine whether the test product, mercaptopurine oral 100 mg/5 mL suspension, and the reference product, Purinethol® 50 mg tablets are bioequivalent. For this purpose the PK profile of 6-mercaptopurine (6-MP) will be compared after administration of a single dose of each of the two formulations, under fasting conditions. The secondary objective is to assess the safety and tolerability of the test product, mercaptopurine oral 100 mg/5 mL suspension.

Conditions

Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Mercaptopurine 20mg/ml Oral Suspension

Group Type: EXPERIMENTAL

Mercaptopurine 20mg/ml oral suspension

Intervention Type: DRUG

50mg

Arm 2

Mercaptopurine 50mg tablets

Group Type: ACTIVE_COMPARATOR

Mercaptopurine 50mg tablet

Intervention Type: DRUG

50mg

Interventions

Mercaptopurine 20mg/ml oral suspension

50mg

Intervention Type: DRUG

Mercaptopurine 50mg tablet

50mg

Intervention Type: DRUG

Other Intervention Names

Xaluprine; Purinethol

Eligibility Criteria

Inclusion Criteria

• Healthy male subjects, 18 years to 50 years inclusive at time of last administration of the IMP.
• Body Mass Index (BMI) between 18.5 and 30 kg/m2.
• Body mass not less than 50 kg.
• Medical history, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations: Findings clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the investigator considers the deviation to be irrelevant for the purpose of the study.
• Non-smokers.

Exclusion Criteria

• Current alcohol use > 21 units of alcohol per week for males.
• Regular exposure to substances of abuse (other than alcohol) within the past year.
• Use of any medication, prescribed or over-the-counter or herbal remedies, within 2 weeks prior to the first administration of IMP except if this will not affect the outcome of the study in the opinion of the investigator.
• Participation in another study with an experimental drug, where the last administration of the previous IMP was within 8 weeks before the first administration of IMP in this study.
• Treatment within the previous 3 months before the first administration of IMP with any drug with a well-defined potential for adversely affecting a major organ or system.
• A major illness during the 3 months before commencement of the screening period.
• Subjects with a deficient, low or intermediate TPMT enzyme activity by means of phenotyping.
• Subjects who participated in previous azathioprine/mercaptopurine studies within six months will be excluded.
• Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome.
• Donation or loss of blood equal to or exceeding 500 mL during the 8 weeks before the first administration of IMP.
• Diagnosis of hypotension or hypertension made during the screening period or current diagnosis of hypertension.
• Resting pulse of > 100 beats per minute or < 45 beats per minute during the screening period, either supine or standing.
• Positive testing for HIV and/or Hepatitis B and/or Hepatitis C.
• Positive urine screen for drugs of abuse.
• Positive urine screen for tobacco use.
• Subjects who plan to procreate within 12 weeks after IMP administration, or not willing to practice reliable forms of contraception during the study and for at least 12 weeks after the last dose of IMP.
• Immunization using a live organism vaccine within 4 weeks prior to the first dosing of IMP.
• Any specific IMP safety concern.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nova Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Parexel International, Bloemfontein Early Phase Clinical Unit

Bloemfontein, , South Africa

Countries

South Africa

Other Identifiers

INV298

Identifier Type: -

Identifier Source: org_study_id