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.

Study Overview

• Status: Terminated
• Conditions: Muscle Atrophy; Hypodynamia
• Intervention / Treatment: Drug: HPP593; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine Division of Geriatrics and Nutritional Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Oral, twice a day.
Experimental: HPP593	Drug: HPP593; Oral, twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Evaluation	Number and severity of adverse events across trial period	Baseline to Day 42

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Muscle Strength	Day 1 to Day 42
Changes on Muscle Related Biomarkers	Day 1 to Day 29

Collaborators and Investigators

• Sponsor: High Point Pharmaceuticals, LLC.
• Investigators: Study Director: Shulin Wang, M.D., High Point Pharmaceuticals, LLC.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: January 27, 2012
• First Submitted That Met QC Criteria: January 30, 2012
• First Posted (Estimate): February 2, 2012

Study Record Updates

• Last Update Posted (Estimate): July 15, 2014
• Last Update Submitted That Met QC Criteria: July 14, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Muscle Atrophy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Dyskinesias; Muscular Atrophy; Atrophy; Hypokinesia
• Other Study ID Numbers: HPP593-103