Study to Evaluatethe Bioavailability and Food Effect Lenalidomide as an Oral Suspension

NCT02521714 | Completed Phase 1

• 1 other identifier: CC-5013-CP-013
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the amount of drug that reaches the circulation when a subject takes the test (liquid) formulation compared to the reference (capsule) formulation. The study will also examine the effect of a high fat meal on the levels of drug in blood.

Conditions

Healthy Volunteers

Keywords

Revlimid; lenalidomide; bioavailability; healthy volunteers; food effect; pharmacokinetics

Outcome Measures

Primary Outcomes (7)

• Pharmacokinetics - AUCt

  Area under the plasma concentration-time curve from time zero to the time of the last measurable concentration

  approximately 11 days

• Pharmacokinetics - AUC∞

  Area under the plasma concentration-time curve from time zero extrapolated to infinity

  approximately 11 days

• Pharmacokinetics - Cmax

  Maximum observed plasma concentration

  approximately 11 days

• Pharmacokinetics - Tmax

  Time to maximum plasma concentration

  approximately 11 days

• Pharmacokinetics - T1/2

  Terminal phase half-life in plasma

  approximately 11 days

• Pharmacokinetics - CL/F

  Apparent total clearance when dosed orally

  approximately 11 days

• Pharmacokinetics - Vz/F

  Apparent volume of distribution when dosed orally

  approximately 11 days

Secondary Outcomes (1)

• Adverse Events (AEs)

  up to 5 weeks

Study Arms (3)

Treatment A: 25mg capsule -under fasted condition

EXPERIMENTAL

Single oral dose of 25mg lenalidomide (reference formulation, 1 x 25mg capsule) under fasted condition.

Drug: Lenalidomide

Treatment B: 25mg oral suspension - under fasted condition

EXPERIMENTAL

Single oral dose of 25mg lenalidomide (test formulation, 2.5mL oral suspension) under fasted condition.

Drug: Lenalidomide

Treatment C: 25mg oral suspension -under fed condition

EXPERIMENTAL

Single oral dose of 25mg lenalidomide (test formulation, 2.5mL oral suspension) under fed condition.

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Also known as: Revlimid®

Treatment A: 25mg capsule -under fasted condition; Treatment B: 25mg oral suspension - under fasted condition; Treatment C: 25mg oral suspension -under fed condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Subjects must satisfy the following criteria to be enrolled in the study:
• Males and females (of non-childbearing potential ) from any race and 18 years of age to 65 years of age at the time of signing the informed consent document.
• Subject must understand and voluntarily sign an informed consent prior to any study-related assessments/procedures being conducted.
• Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
• Must be able to communicate with the investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules
• Male subjects
• Must agree to practice complete abstinence (True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence \[eg, calendar, ovulation, symptothermal or, post ovulation methods\] and withdrawal are not acceptable methods of contraception.) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential (FCBP) while taking lenalidomide, during dose interruptions, and for at least 28 days after the last dose of lenalidomide, even if he has undergone a successful vasectomy.
• Must not donate semen or sperm while receiving lenalidomide, during dose interruptions, and for at least 28 days after the last dose of lenalidomide.
• Counseling about pregnancy precautions and the potential risks of fetal exposure must be conducted as described in the Lenalidomide Pregnancy Prevention Plan.
• Must have a body mass index (BMI) between 18 and 33 kg/m2 (inclusive).
• Clinical laboratory tests must be within normal limits or considered not clinically significant by the investigator.
• Must have confirmation of normal renal function.
• Must be afebrile with supine systolic blood pressure: 90 to 140 mmHg, supine diastolic blood pressure: 50 to 90 mmHg, and pulse rate: 40 to 110 beats per minute at the screening visit. Vital signs may be repeated up to three times to determine eligibility.
• Must have a normal or clinically acceptable 12-lead electrocardiogram, with a QTcF value ≤ 450 msec for male subjects or ≤ 470 msec for female subjects.

You may not qualify if:

• \- The presence of any of the following will exclude a subject from enrollment:
• Any significant medical condition (e.g., renal insufficiency), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
• Any condition that confounds the ability to interpret data from the study.
• Used any prescribed systemic or topical medication within 30 days of the first dose administration, unless Sponsor agreement is obtained.
• Used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration, unless Sponsor agreement is obtained.
• Has any surgical or medical conditions (excluding appendectomy) possibly affecting drug absorption, distribution, metabolism and excretion, eg, bariatric procedure, cholecystectomy.
• Donated blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.
• History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual within 2 years before the first dose administration, or positive drug screening test reflecting consumption of illicit drugs.
• History of alcohol abuse (as defined by the current version of the DSM) within 2 years before the first dose administration , or positive alcohol screen.
• Known to have serum hepatitis or known to be a carrier of the hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb), or have a positive result to the test for HIV antibodies at Screening.
• Exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer).

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Covance-Daytona Beach

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

Lenalidomide

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Francisco Ramirez-Valle, MD, PhD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 13, 2015
• Study Start: August 14, 2015
• Primary Completion: September 23, 2015
• Study Completion: September 23, 2015
• Last Updated: November 8, 2019

Record last verified: 2019-11

Locations

US (1)