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 |
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.
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.
We found this trial at
1
site
St. Louis, Missouri 63110
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