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

November 6, 2019 updated by: Celgene

A Phase 1, Open-label, Randomized, Three-period, Two-way Crossover Study in Healthy Subjects to Evaluate the Bioavailability of a Test Lenalidomide Oral Suspension Relative to the Reference Capsule Formulation and to Assess the Effect of Food on the Bioavailability of Lenalidomide From the Oral Suspension

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a phase 1, open-label, randomized, three-period, two-way crossover study in healthy subjects. The study will consist of a screening phase, a baseline phase, three treatment periods, and a follow-up phone call. Each period will be two days in duration (Day 1 through Day 2) for dosing and sample collection. There will be a minimum of four days washout between doses.

Within no more than 21 days (Day -21) and no less than two days (Day -2) prior to the start of Period 1, subjects will undergo routine screening procedures including physical examination (PE), 12-lead electrocardiogram (ECG), vital signs, clinical laboratory safety tests (serum chemistry, hematology, and urinalysis), serology screen, and drug/alcohol screen.

Eligible subjects will be admitted into the study center on Day -1 of Period 1 for baseline assessments. During each period, subjects will receive a single 25 mg oral dose of lenalidomide on Day 1 according to the assigned treatment sequence. Serial blood sampling for the determination of lenalidomide concentrations in plasma will be performed for 24 hours post dose, and safety will be evaluated. Subjects will be domiciled at the study center from Day 1 of Period 1 through Day 2 of Period 3, including the 4 day washout between each dose of IP. All subjects will be discharged from the study center on Day 2 of Period 3 following completion of required study procedures.

A follow-up phone call will occur approximately four days (±2 days) after discharge from the study center.

The study will be conducted in compliance with International Conference on Harmonisation (ICH) Good Clinical Practices (GCPs).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Covance-Daytona Beach

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Subjects must satisfy the following criteria to be enrolled in the study:

  1. 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.
  2. Subject must understand and voluntarily sign an informed consent prior to any study-related assessments/procedures being conducted.
  3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
  4. 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

  5. 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.
  6. Counseling about pregnancy precautions and the potential risks of fetal exposure must be conducted as described in the Lenalidomide Pregnancy Prevention Plan.
  7. Must have a body mass index (BMI) between 18 and 33 kg/m2 (inclusive).
  8. Clinical laboratory tests must be within normal limits or considered not clinically significant by the investigator.
  9. Must have confirmation of normal renal function.
  10. 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.
  11. 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.

Exclusion Criteria:

- The presence of any of the following will exclude a subject from enrollment:

  1. Any significant medical condition (e.g., renal insufficiency), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  2. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
  3. Any condition that confounds the ability to interpret data from the study.
  4. Used any prescribed systemic or topical medication within 30 days of the first dose administration, unless Sponsor agreement is obtained.
  5. 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.
  6. Has any surgical or medical conditions (excluding appendectomy) possibly affecting drug absorption, distribution, metabolism and excretion, eg, bariatric procedure, cholecystectomy.
  7. Donated blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.
  8. 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.
  9. 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.
  10. 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.
  11. 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment A: 25mg capsule -under fasted condition
Single oral dose of 25mg lenalidomide (reference formulation, 1 x 25mg capsule) under fasted condition.
Drug: Lenalidomide
Other Names:
  • Revlimid®
Experimental: Treatment B: 25mg oral suspension - under fasted condition
Single oral dose of 25mg lenalidomide (test formulation, 2.5mL oral suspension) under fasted condition.
Drug: Lenalidomide
Other Names:
  • Revlimid®
Experimental: Treatment C: 25mg oral suspension -under fed condition
Single oral dose of 25mg lenalidomide (test formulation, 2.5mL oral suspension) under fed condition.
Drug: Lenalidomide
Other Names:
  • Revlimid®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics - AUCt
Time Frame: approximately 11 days
Area under the plasma concentration-time curve from time zero to the time of the last measurable concentration
approximately 11 days
Pharmacokinetics - AUC∞
Time Frame: approximately 11 days
Area under the plasma concentration-time curve from time zero extrapolated to infinity
approximately 11 days
Pharmacokinetics - Cmax
Time Frame: approximately 11 days
Maximum observed plasma concentration
approximately 11 days
Pharmacokinetics - Tmax
Time Frame: approximately 11 days
Time to maximum plasma concentration
approximately 11 days
Pharmacokinetics - T1/2
Time Frame: approximately 11 days
Terminal phase half-life in plasma
approximately 11 days
Pharmacokinetics - CL/F
Time Frame: approximately 11 days
Apparent total clearance when dosed orally
approximately 11 days
Pharmacokinetics - Vz/F
Time Frame: approximately 11 days
Apparent volume of distribution when dosed orally
approximately 11 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Events (AEs)
Time Frame: up to 5 weeks
Number of participants with adverse events
up to 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Francisco Ramirez-Valle, MD, PhD, Celgene Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CC-5013-CP-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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