Safety Study of HPP593 in Subjects During and After Limb Immobilization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Muscle Atrophy Hypodynamia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HPP593

Group Type EXPERIMENTAL

HPP593

Intervention Type DRUG

Oral, twice a day.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral, twice a day.

Interventions

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HPP593

Oral, twice a day.

Intervention Type DRUG

Placebo

Oral, twice a day.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes