Safety Study of HPP593 in Subjects During and After Limb Immobilization

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Muscle Atrophy, Hypodynamia

In brief

This is a safety and tolerability study investigating the effect of HPP593 in healthy volunteers during and after limb immobilization.

Key facts

Study ID

NCT01524406

Run by

High Point Pharmaceuticals, LLC.

People needed

24

Starts

2012-01-01

Expected to finish

2013-06-01

Last updated by the study team

2014-07-15

Who can join

Age: 30 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Washington University School of Medicine Division of Geriatrics and Nutritional Studies — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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