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Clinical Trials/NL-OMON50544
NL-OMON50544CompletedNot Applicable

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

Starton Therapeutics0 sites16 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
16
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 64 (—)

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.

Investigators

Sponsor
Starton Therapeutics

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