Safety Study of HPP593 in Subjects During and After Limb Immobilization

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
High Point Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT01524406
First received: January 27, 2012
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Muscle Atrophy
Hypodynamia
Drug: HPP593
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by High Point Pharmaceuticals, LLC.:

Primary Outcome Measures:
  • Safety Evaluation [ Time Frame: Baseline to Day 42 ] [ Designated as safety issue: No ]
    Number and severity of adverse events across trial period


Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: January 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HPP593 Drug: HPP593
Oral, twice a day.
Placebo Comparator: Placebo Drug: Placebo
Oral, twice a day.

  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: High Point Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT01524406     History of Changes
Other Study ID Numbers: HPP593-103
Study First Received: January 27, 2012
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 22, 2014