A Pilot Bioequivalence Study of Pomalidomide

NCT06058689 | Unknown Phase 1 DMC

• 1 other identifier: Pomalidomide
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bioequivalence Study

Outcome Measures

Primary Outcomes (3)

• 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%

Study Arms (2)

Pomalidomide Test

EXPERIMENTAL

Pomalidomide 4 MG Oral Capsule per os,1 capsule per period

Drug: Pomalidomide 4 MG Oral Capsule

Pomalidomide Reference

EXPERIMENTAL

Pomalidomide 4 MG Oral Capsule (Pomalyst) per os,1 capsule per period

Drug: Pomalidomide 4 MG Oral Capsule

Interventions

Pomalidomide 4 MG Oral Capsule DRUG

A single dose of 4 mg Pomalidomide per os, capsule, 4 mg, per period

Also known as: Pomalyst, Pomalidomide Megalabs

Pomalidomide Reference; Pomalidomide Test

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Megalabs: lead

Study Sites (1)

Azidus Laboratories

Chennai, Tamil Nadu, 600127, India

Location

MeSH Terms

Interventions

pomalidomide

Study Officials

• M. Gowtham, MD

  Azidus Laboratories

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcos Giusti, MD

CONTACT

+ (598) 2683 8000; mgiusti@megalabs.global

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An open label, balanced, randomized, two treatments, two sequences, two periods, single dose, crossover, bioequivalence study.

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 28, 2023
• Study Start: September 15, 2024
• Primary Completion: November 15, 2024
• Study Completion: March 15, 2025
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)