Safety Study of HPP593 in Subjects During and After Limb Immobilization

Phase 1

Terminated

• Conditions: Hypodynamia; Muscle Atrophy
• Interventions: Drug: Placebo; Drug: HPP593

• Registration Number: NCT01524406
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-27
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-02-02
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-14
• Last Update Posted: 2014-07-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
HPP593	HPP593	-

Primary Outcome Measures

Name	Time	Method
Safety Evaluation	Baseline to Day 42	Number and severity of adverse events across trial period

Secondary Outcome Measures

Name	Time	Method
Changes on Muscle Related Biomarkers	Day 1 to Day 29
Change in Muscle Strength	Day 1 to Day 42

Trial Locations

Locations (1)

Washington University School of Medicine Division of Geriatrics and Nutritional Studies; 🇺🇸 St. Louis, Missouri, United States