An Open-label, Randomized, Crossover, Single Ascending Dose Pharmacokinetic Study of Continuous Subcutaneous Infusion of Lenalidomide Compared with Revlimid® Oral Capsules in Healthy Adult Male Subjects

An Open-label, Randomized, Crossover, Single Ascending Dose Pharmacokinetic Study of Continuous Subcutaneous Infusion of Lenalidomide Compared with Revlimid® Oral Capsules in Healthy Adult Male Subjects - Lenalidomide single ascending dose study in healthy male subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50544

Enrollment

Registered

2021-10-21

Start date

2022-03-30

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blood cancer multiple myeloma

Interventions

The dose for the next group will only be increased if the lower dose of the previous group was found to be well tolerated and in case of no objection by the Medical Research Ethics Committee. The st

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Gender : Male. 2. Age : 18 years to 55 years, inclusive, at screening. 3. Body mass index (BMI) : 18.0 kg/m2 to 32.0 kg/m2, inclusive at screening. 4. Weight : 50 kg to 110 kg, inclusive, at screening. 5. Status : Healthy subjects. 6. Creatinine clearance >61 mL/min (by Chronic Kidney Disease Epidemiology Collaboration).

Exclusion criteria

Exclusion criteria: 1. Employee of PRA or the sponsor. 2. History of relevant drug and/or food allergies. 3. History of alcohol abuse or drug addiction (including soft drugs like cannabis products). 4. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and admission to the clinical research center. 5. Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits). 6. Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies.

Design outcomes

Primary

Measure	Time frame
To assess and compare the pharmacokinetics (PK) of a 24-hour continuous subcutaneous (SC) infusion of lenalidomide versus lenalidomide oral capsules (Revlimid) in healthy adult male subjects at 3 escalating infusion rates and reference oral doses.	—

Secondary

Measure	Time frame
- To evaluate the relative bioavailability of a 24-hour continuous SC infusion of lenalidomide versus Revlimid oral capsules in healthy adult male subjects - To evaluate the safety and tolerability of a 24-hour continuous SC infusion of lenalidomide versus Revlimid oral capsules in healthy adult male subjects	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)