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Safety Study of HPP593 in Subjects During and After Limb Immobilization

This study is currently recruiting participants.
Verified May 2012 by High Point Pharmaceuticals, LLC.
Sponsor:
Information provided by (Responsible Party):
High Point Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT01524406
First received: January 27, 2012
Last updated: May 25, 2012
Last verified: May 2012
History of Changes

January 27, 2012
May 25, 2012
January 2012
December 2012   (final data collection date for primary outcome measure)
Safety Evaluation [ Time Frame: Baseline to Day 42 ] [ Designated as safety issue: No ]
Number and severity of adverse events across trial period
Same as current
Complete list of historical versions of study NCT01524406 on ClinicalTrials.gov Archive Site
  • Change in Muscle Strength [ Time Frame: Day 1 to Day 42 ] [ Designated as safety issue: No ]
  • Changes on Muscle Related Biomarkers [ Time Frame: Day 1 to Day 29 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
  • Muscle Atrophy
  • Hypodynamia
  • Drug: HPP593
    Oral, twice a day.
  • Drug: Placebo
    Oral, twice a day.
  • Experimental: HPP593
    Intervention: Drug: HPP593
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Male
30 Years to 55 Years
Yes
Contact: Shulin Wang, M.D. ClinicalTrials@ttpharma.com
United States
 
NCT01524406
HPP593-103
No
High Point Pharmaceuticals, LLC.
High Point Pharmaceuticals, LLC.
Not Provided
Study Director: Shulin Wang, M.D. High Point Pharmaceuticals, LLC.
High Point Pharmaceuticals, LLC.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP