Status:
TERMINATED
Safety Study of HPP593 in Subjects During and After Limb Immobilization
Lead Sponsor:
High Point Pharmaceuticals, LLC.
Conditions:
Muscle Atrophy
Hypodynamia
Eligibility:
MALE
30-55 years
Phase:
PHASE1
Brief Summary
This is a safety and tolerability study investigating the effect of HPP593 in healthy volunteers during and after limb immobilization.
Eligibility Criteria
Inclusion
- Non-smoking.
- Subjects must be in good health, as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical test results.
- Not restricted to a wheel-chair or confined to a bed.
- Weight ≥ 50.0 kg.
- BMI between 18 and 27.5 kg/m2, inclusive, at the time of screening.
Exclusion
- Any of the following abnormalities at Screening Visit and Baseline:
- Fasting glucose \> 110 mg/dL (Screening visit only).
- Serum creatinine \> 1.5 mg/dL. If serum creatinine is \>1.5 mg/dL and creatinine clearance is \>60 mL/min, the subject need not be excluded
- Troponin I level above the upper limit of normal (ULN)
- Liver function tests (LFTs) \> 1.5x ULN
- Evidence of significant organ system dysfunction (e.g. diabetes, cardiovascular disease, cirrhosis, hypogonadism, hypo- or hyperthyroidism; hypertension)
- Any fluctuations in weight (no more than ± 2% of body weight) by subject self report in the 3 months prior to the Screening Visit.
- Has received HPP593 in a previous clinical trial.
- Smoking within 6 month prior to Day -1.
- Michigan Alcohol Screening Test score greater than 2.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01524406
Start Date
January 1 2012
End Date
June 1 2013
Last Update
July 15 2014
Active Locations (1)
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1
Washington University School of Medicine Division of Geriatrics and Nutritional Studies
St Louis, Missouri, United States, 63110