A Pilot Bioequivalence Study of Pomalidomide

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

Pomalidomide capsule were developed to offer an alternative to the marketed formulation, This pilot study was aim to pre-assess the bioequivalence of the capsule formulations under fasted condition.

Study Overview

• Status: Completed
• Conditions: Bioequivalence
• Intervention / Treatment: Drug: Pomalidomide 4 MG Oral Capsule; Drug: Pomalidomide 4 MG Oral Capsule-Pomalyst

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • The Second Hospital of Shanxi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Subjects should read, sign and date an Informed Consent Form and be fully informed of possible adverse events prior to any study procedures.
• Subjects should complete the trial according to the regulations.
• Subjects must agree to take effective contraceptive methods to prevent pregnancy from 2 weeks before screening until 3 months of last dose administration. Subjects must agree to avoid semen and blood donation until 3 months of last dose administration.
• Healthy male volunteers of 18-50 years old.
• Body mass index (BMI) ranges from 18.0 to 28.0 kg/m2, body weight ≥ 50 kg.
• Medically healthy subjects with clinically normal Neutrophils and Platelets within 14 days.
• No history of heart, liver, kidney, gastrointestinal tract diseases, nervous system, neural abnormities or metabolic abnormalities.

Exclusion Criteria:

• Smokers (>3 cigarettes/day)
• History of allergic reactions to pomalidomide or Thalidomide analogues. Any food allergies, which in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study.
• Any history of thrombus or liver, kidney diseases.
• History of Alcohol abuse (3990 ml beer, 1400 ml wine, 350 ml spirits/week)
• Recent donation of plasma or significant loss of whole blood (>400 ml) within 3 months.
• Subjects have difficulty to swallow or any clinical significant history of ongoing gastrointestinal problems which affect absorption of drugs.
• Received a prescription medicine within 2 weeks prior to study dosing.
• Received a non-prescription drugs, traditional Chinese medicine, health products within prior to study dosing.
• Received a special food (dragon fruit, grapefruit or other tropical fruit) or strenuous exercise within 1 week prior to study dosing. Regular use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to study administration.
• Any anticipation in other trial within 3 months.
• Abnormal laboratory tests judged clinically significant.
• Positive test result for HBsAg, HBeAg, HBeAb, HBcAB, HCvAB, HIV antibody, Syphilis screening antibody.
• Received a caffeine/Xanthine beverages or food within 48 h prior to study dosing.
• Received an alcohol within 24 h prior to study dosing or positive test result for alcohol screening.
• Positive test result for drugs of abuse.
• Other reasons which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pomalidomide 4 MG Oral Capsule; per os,capsule,4mg,1 capsule per period	Drug: Pomalidomide 4 MG Oral Capsule; per os,capsule,4mg,1 capsule per period
Experimental: Pomalidomide 4 MG Oral Capsule-Pomalyst; per os,capsule,4mg,1 capsule per period	Drug: Pomalidomide 4 MG Oral Capsule-Pomalyst; per os,capsule,4mg,1 capsule per period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax)	90% CI of T/R within 80-125%	Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
Area under the plasma concentration versus time curve from 0 to the last measurable concentration (AUC0-t)	90% CI of T/R within 80-125%	Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
Area under the plasma concentration versus time curve from 0 to infinity (AUC0-inf)	90% CI of T/R within 80-125%	Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.

Collaborators and Investigators

• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Collaborators: Second Hospital of Shanxi Medical University
• Investigators: Principal Investigator: Ruigang Hou, Bachelor, Second Hospital of Shanxi Medical University; Principal Investigator: Linhua Linhua, PhD, Second Hospital of Shanxi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2018
• Primary Completion (Actual): January 29, 2018
• Study Completion (Actual): February 6, 2018

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Multiple myeloma; Pomalidomide; Bioequivalence
• 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: XS-2017-001-SXYK

Drug and device information, study documents

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