A Pilot Bioequivalence Study of Pomalidomide

A Pilot, Open-label, Randomized, Two-Way Crossover, Single-Dose Bioequivalence Study of Pomalidomide Under Fasting Condition in Indian Healthy Volunteers

Pilot bioequivalence trial of two pomalidomide formulations consisting in 4 mg oral capsules.

Study Overview

• Status: Not yet recruiting
• Conditions: Bioequivalence Study
• Intervention / Treatment: Drug: Pomalidomide 4 MG Oral Capsule

Detailed Description

An open label, balanced, randomized, two treatments, two sequences, two periods, single dose, crossover assignment, bioequivalence study of Pomalidomide 4 mg Capsules of Mega Labs S.A and Pomalyst® (Pomalidomide) 4 mg capsules of Celgene International SARL, Boudry, Switzerland in healthy, adult, human male subjects under fasting condition.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Marcos Giusti, MD; Phone Number: + (598) 2683 8000; Email: mgiusti@megalabs.global

Study Locations

• India
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600127
      • Azidus Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Healthy male literate volunteers of 18 to 45 years with BMI of 18.50 - 29.99 Kg/m2 and weight > 50 Kg.

Healthy volunteers as evaluated by medical history, vitals and general clinical examination.

Normal or clinically insignificant biochemical, hematological, urine and serology parameters.

Normal or clinically insignificant ECG. Negative urine test for drugs of abuse, alcohol breath analysis. Volunteers who are willing to use acceptable methods of contraception. Volunteers who can give written informed consent and communicate effectively.

Exclusion Criteria:

History of any major surgical procedure in the past 03 months. History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders.

History of chronic alcoholism/ chronic smoking/ drug of abuse. Volunteers with known hypersensitivity to Pomalidomide or any of the excipients.

History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing Volunteer who are positive for hepatitis B surface antigen, anti-hepatitis C antibody, treponemal antibodies and human immunodeficiency virus (HIV 1&2) antibodies.

Present or past history of intake of drugs or any prescription drug or over the counter (OTC) drugs within 14 days which potentially modify kinetics / dynamics of Pomalidomide or any other medication judged to be clinically significant by the investigator.

History of consumption of grapefruit and/or its products within 10 days prior to the start of study.

Volunteer who had participated in any other clinical study or who had bled during the last 03 months before check-in.

History of consumption of one or more of the below, 48 hours prior to dosing: Xanthine containing food or drinks such as cola, chocolate, coffee or tea, citrus fruits or items (lime, lemon and orange), alcohol and any other food/beverage known to have interactions as deemed by the investigator Volunteers who are dysphagic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pomalidomide Test; Pomalidomide 4 MG Oral Capsule per os,1 capsule per period	Drug: Pomalidomide 4 MG Oral Capsule; A single dose of 4 mg Pomalidomide per os, capsule, 4 mg, per period; Other Names: Pomalyst, Pomalidomide Megalabs
Experimental: Pomalidomide Reference; Pomalidomide 4 MG Oral Capsule (Pomalyst) per os,1 capsule per period	Drug: Pomalidomide 4 MG Oral Capsule; A single dose of 4 mg Pomalidomide per os, capsule, 4 mg, per period; Other Names: Pomalyst, Pomalidomide Megalabs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Peak Plasma Concentration (Cmax). T/R of Cmax R within 80-125% for IC 90% vs the Comparator; also to generate pharmacokinetic data that can be used to design a pivotal bioequivalence study.	Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
AUC0-t	Area under the plasma concentration versus time curve from 0 to the last measurable concentration (AUC0-t). T/R of AUC 0-t within 80-125% for 90% CI vs the Comparator.	Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2. 90% CI of T/R within 80-125%
AUC0-inf	Area under the plasma concentration versus time curve from 0 to the last measurable concentration (AUC0-t). T/R of AUC 0-t within 80-125% for 90% CI vs the Comparator.	Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2. 90% CI of T/R within 80-125%

Collaborators and Investigators

• Sponsor: Megalabs
• Investigators: Principal Investigator: M. Gowtham, MD, Azidus Laboratories

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2024
• Primary Completion (Estimated): November 15, 2024
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: September 15, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Thalidomide; Pomalidomide
• Other Study ID Numbers: Pomalidomide

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No