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

Completed

• Conditions: blood cancer; multiple myeloma; 10025323

• Registration Number: NL-OMON50544
• Lead Sponsor: Starton Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2022-11-17
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess and compare the pharmacokinetics (PK) of a 24-hour continuous<br /><br>subcutaneous (SC) infusion of lenalidomide versus lenalidomide oral capsules<br /><br>(Revlimid) in healthy adult male subjects at 3 escalating infusion rates and<br /><br>reference oral doses.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To evaluate the relative bioavailability of a 24-hour continuous SC infusion<br /><br>of lenalidomide versus Revlimid oral capsules in healthy adult male subjects<br /><br>- To evaluate the safety and tolerability of a 24-hour continuous SC infusion<br /><br>of lenalidomide versus Revlimid oral capsules in healthy adult male subjects</p><br>