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
1 other identifier
interventional
24
1 country
1
Brief Summary
This is a safety and tolerability study investigating the effect of HPP593 in healthy volunteers during and after limb immobilization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 27, 2012
CompletedFirst Posted
Study publicly available on registry
February 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJuly 15, 2014
July 1, 2014
1.4 years
January 27, 2012
July 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety Evaluation
Number and severity of adverse events across trial period
Baseline to Day 42
Secondary Outcomes (2)
Change in Muscle Strength
Day 1 to Day 42
Changes on Muscle Related Biomarkers
Day 1 to Day 29
Study Arms (2)
HPP593
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine Division of Geriatrics and Nutritional Studies
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shulin Wang, M.D.
High Point Pharmaceuticals, LLC.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2012
First Posted
February 2, 2012
Study Start
January 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
July 15, 2014
Record last verified: 2014-07