Safety Study of HPP593 in Subjects During and After Limb Immobilization



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - 55
Updated:5/5/2014
Start Date:January 2012
End Date:December 2012
Contact:Shulin Wang, M.D.
Email:ClinicalTrials@ttpharma.com

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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.
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