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