Comparative assessment of the absorption of a generic formulation of 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione capsule against the innovator 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione capsule conducted under fasting conditions in healthy male volunteers.

Phase 1

Completed

• Conditions: 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione is indicated for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.; Blood - Other blood disorders; Cancer - Myeloma

• Registration Number: ACTRN12619001352190
• Lead Sponsor: Zenith Technology Corporation Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-01
• Study Completion: 2019-10-14
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 31

Inclusion Criteria

Healthy males
Aged between 18 and 55 years
Non-smoker
BMI greater than or equal to 18.5 and less than 30 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Drug free as determined by urine drug testing
Able to comply with the study restrictions
Able to provide written informed consent

Exclusion Criteria

Females
Clinically significant medical conditions
History of conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
History of alcohol or drug abuse or dependency
Participation in a drug study within 30 days of the start of the study
Sensitivitie to the study drug or excipients
Individuals for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the pharmacokinetics (as summarised by Cmax and AUC) of the test formulation relative to that of the reference formulation. All plasma samples will be assayed for 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione using one fully validated LC/MS/MS method. Validation will be conducted to comply with FDA guidelines.[ 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours post dosing.]

Secondary Outcome Measures

Name	Time	Method
Time to maximum peak concentration (Tmax) will be determined by plasma sample analysis. Tmax will be the time where the maximum concentration occurred in the sample points.[ 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours post dosing.]