Healthy VolunteersPhase 1NCT02521714
Study to Evaluatethe Bioavailability and Food Effect Lenalidomide as an Oral Suspension
A Phase 1 study testing Lenalidomide in people with Healthy Volunteers, run by Celgene at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2015to 23 Sep 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Healthy Volunteers
- Being tested
- Lenalidomide
- Keywords
- Revlimid, lenalidomide, bioavailability, healthy volunteers, food effect, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid®
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: 25mg capsule -under fasted condition | Experimental | Single oral dose of 25mg lenalidomide (reference formulation, 1 x 25mg capsule) under fasted condition. Receives: 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. Receives: 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. Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - AUCt
Area under the plasma concentration-time curve from time zero to the time of the last measurable concentration
Measured: approximately 11 days
Pharmacokinetics - AUC∞
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Measured: approximately 11 days
Pharmacokinetics - Cmax
Maximum observed plasma concentration
Measured: approximately 11 days
Pharmacokinetics - Tmax
Time to maximum plasma concentration
Measured: approximately 11 days
Pharmacokinetics - T1/2
Terminal phase half-life in plasma
Measured: approximately 11 days
Pharmacokinetics - CL/F
Apparent total clearance when dosed orally
Measured: approximately 11 days
Pharmacokinetics - Vz/F
Apparent volume of distribution when dosed orally
Measured: approximately 11 days
Secondary outcomes (1)
Adverse Events (AEs)
Number of participants with adverse events
Measured: up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start14 Aug 2015
- Primary completion23 Sep 2015
- Study completion23 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco Ramirez-Valle, MD, PhD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521714
- Sponsor's protocol ID
- CC-5013-CP-013
- Status last verified
- Nov 2019
- First submitted
- 11 Aug 2015
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02521714
- Acronym / sponsor ID
- CC-5013-CP-013
- Conditions
- Healthy Volunteers
- Keywords
- Revlimid, lenalidomide, bioavailability, healthy volunteers, food effect, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2015 (actual)
- Primary completion
- 23 Sep 2015 (actual)
- Study completion
- 23 Sep 2015 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A: 25mg capsule -under fasted condition | Experimental | Drug: LenalidomideSingle oral dose of 25mg lenalidomide (reference formulation, 1 x 25mg capsule) under fasted condition. |
| Treatment B: 25mg oral suspension - under fasted condition | Experimental | Drug: LenalidomideSingle oral dose of 25mg lenalidomide (test formulation, 2.5mL oral suspension) under fasted condition. |
| Treatment C: 25mg oral suspension -under fed condition | Experimental | Drug: LenalidomideSingle oral dose of 25mg lenalidomide (test formulation, 2.5mL oral suspension) under fed condition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenalidomideAlso: Revlimid® | Drug | Treatment A: 25mg capsule -under fasted condition, Treatment B: 25mg oral suspension - under fasted condition, Treatment C: 25mg oral suspension -under fed condition |
Primary outcome
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
Pharmacokinetics - AUC∞
Time frame: approximately 11 days
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Pharmacokinetics - Cmax
Time frame: approximately 11 days
Maximum observed plasma concentration
Pharmacokinetics - Tmax
Time frame: approximately 11 days
Time to maximum plasma concentration
Pharmacokinetics - T1/2
Time frame: approximately 11 days
Terminal phase half-life in plasma
Pharmacokinetics - CL/F
Time frame: approximately 11 days
Apparent total clearance when dosed orally
Pharmacokinetics - Vz/F
Time frame: approximately 11 days
Apparent volume of distribution when dosed orally
1 secondary outcome
Adverse Events (AEs)
Time frame: up to 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Ramirez-Valle, MD, PhD study director
Celgene Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lenalidomide in people with Healthy Volunteers, run by Celgene at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics - AUCt (time frame: approximately 11 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.