Safety Study of HPP593 in Subjects During and After Limb Immobilization

Muscle Atrophy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01524406
• Other study ID #: HPP593-103
• Status: Terminated
• Phase: Phase 1
• First received: January 27, 2012
• Last updated: July 14, 2014
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2014
• Source: High Point Pharmaceuticals, LLC.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypodynamia
• Muscle Atrophy
• Muscular Atrophy

Intervention

Drug:
• HPP593
Oral, twice a day.
• Placebo
Oral, twice a day.

Locations

Country	Name	City	State
United States	Washington University School of Medicine Division of Geriatrics and Nutritional Studies	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
High Point Pharmaceuticals, LLC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Evaluation	Number and severity of adverse events across trial period	Baseline to Day 42	No
Secondary	Change in Muscle Strength		Day 1 to Day 42	No
Secondary	Changes on Muscle Related Biomarkers		Day 1 to Day 29	No