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Safety Study of HPP593 in Subjects During and After Limb Immobilization

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ClinicalTrials.gov Identifier: NCT01524406
Recruitment Status : Terminated
First Posted : February 2, 2012
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
High Point Pharmaceuticals, LLC.

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

Condition or disease Intervention/treatment Phase
Muscle Atrophy Hypodynamia Drug: HPP593 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : January 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
Experimental: HPP593 Drug: HPP593
Oral, twice a day.

Placebo Comparator: Placebo Drug: Placebo
Oral, twice a day.




Primary Outcome Measures :
  1. Safety Evaluation [ Time Frame: Baseline to Day 42 ]
    Number and severity of adverse events across trial period


Secondary Outcome Measures :
  1. Change in Muscle Strength [ Time Frame: Day 1 to Day 42 ]
  2. Changes on Muscle Related Biomarkers [ Time Frame: Day 1 to Day 29 ]


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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524406


Locations
United States, Missouri
Washington University School of Medicine Division of Geriatrics and Nutritional Studies
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
High Point Pharmaceuticals, LLC.
Investigators
Study Director: Shulin Wang, M.D. High Point Pharmaceuticals, LLC.

Responsible Party: High Point Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT01524406     History of Changes
Other Study ID Numbers: HPP593-103
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: July 2014

Keywords provided by High Point Pharmaceuticals, LLC.:
Muscle Atrophy

Additional relevant MeSH terms:
Atrophy
Muscular Atrophy
Hypokinesia
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dyskinesias