Back to resultsSafety Study of HPP593 in Subjects During and After Limb Immobilization
Primary Purpose
Muscle Atrophy, Hypodynamia
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HPP593
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Muscle Atrophy focused on measuring Muscle Atrophy
Eligibility 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.
Sites / Locations
- Washington University School of Medicine Division of Geriatrics and Nutritional Studies
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HPP593
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Safety Evaluation
Number and severity of adverse events across trial period
Secondary Outcome Measures
Change in Muscle Strength
Changes on Muscle Related Biomarkers
Full Information
NCT ID
NCT01524406
First Posted
January 27, 2012
Last Updated
July 14, 2014
Sponsor
High Point Pharmaceuticals, LLC.
1. Study Identification
Unique Protocol Identification Number
NCT01524406
Brief Title
Safety Study of HPP593 in Subjects During and After Limb Immobilization
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 Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
High Point Pharmaceuticals, LLC.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a safety and tolerability study investigating the effect of HPP593 in healthy volunteers during and after limb immobilization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Atrophy, Hypodynamia
Keywords
Muscle Atrophy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HPP593
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HPP593
Intervention Description
Oral, twice a day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral, twice a day.
Primary Outcome Measure Information:
Title
Safety Evaluation
Description
Number and severity of adverse events across trial period
Time Frame
Baseline to Day 42
Secondary Outcome Measure Information:
Title
Change in Muscle Strength
Time Frame
Day 1 to Day 42
Title
Changes on Muscle Related Biomarkers
Time Frame
Day 1 to Day 29
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shulin Wang, M.D.
Organizational Affiliation
High Point Pharmaceuticals, LLC.
Official's Role
Study Director
Facility Information:
Facility Name
Washington University School of Medicine Division of Geriatrics and Nutritional Studies
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
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Safety Study of HPP593 in Subjects During and After Limb Immobilization
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