NL-OMON38062CompletedNot Applicable
A PHASE I, SINGLE CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, SINGLE DOSE STUDY IN HEALTHY FEMALE AND ELDERLY VOLUNTEERS AND MULTIPLE ASCENDING DOSE STUDY IN HEALTHY MALE AND FEMALE VOLUNTEERS BETWEEN THE AGES OF 18-80 YEARS TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF GRC 17536 - SAD and MAD study of GRC 17536 in healthy volunteers
Glenmark Pharmaceuticals SA0 sites74 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 74
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Part 1: healthy females, 18 - 45 and 46 - 65 years of age, BMI 18.0 - 30.0 kg/m2, no smokers
- •Part 2: healthy elderly males and females, 65 - 80 years of age, BMI 18.0 - 30.0 kg/m2, no smokers
- •Part 3: healthy young and elderly males, 18 - 45 and 65 - 80 years of age, and healthy young and elderly females, 18 - 45 years of age and 65 - 80 years of age, BMI 18.0 - 30.0 kg/m2, no smokers
- •Part 4: healthy males, 18 - 45 years of age, BMI 18.0 - 30.0 kg/m2, no smokers;18 - 80 years of age, male and female, BMI 18.0 - 30.0 kg/m2, no smokers.
Exclusion Criteria
- •Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of have taken part in more than 3 other drug studies (for men) or more than 2 other drug studies (for women) in the 10 months prior to the start of this study, or when having donated more than 1.5 liters of blood (for men) or more than 1.0 liters of blood (for women) in the 10 months prior to the start of this study
Investigators
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