Safety Study of HPP593 in Subjects During and After Limb Immobilization

A Randomized, Double-blind, Placebo Controlled, Phase I Study to Evaluate the Safety and Tolerability of 28 Day Treatment With HPP593 Capsules in Healthy Volunteers During and After Limb Immobilization

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

Inclusion Criteria:

• 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 Criteria:

• 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.