NCT01524406
Terminated
Phase 1
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
High Point Pharmaceuticals, LLC.1 site in 1 country24 target enrollmentStarted: January 2012Last updated:
Overview
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Safety Evaluation
Overview
Brief Summary
This is a safety and tolerability study investigating the effect of HPP593 in healthy volunteers during and after limb immobilization.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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 -
- •Michigan Alcohol Screening Test score greater than 2.
Arms & Interventions
HPP593
Experimental
Intervention: HPP593 (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Safety Evaluation
Time Frame: Baseline to Day 42
Number and severity of adverse events across trial period
Secondary Outcomes
- Changes on Muscle Related Biomarkers(Day 1 to Day 29)
- Change in Muscle Strength(Day 1 to Day 42)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Terminated
Phase 1
Safety Study of HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's DiseaseMild Alzheimer's DiseaseMild Cognitive ImpairmentNCT01482013High Point Pharmaceuticals, LLC.7
Completed
Phase 2
Phase 2 Study of INV-202 in Patients With Diabetic Kidney DiseaseDiabetic Kidney DiseaseNCT05514548Inversago Pharma Inc.265
Completed
Phase 1
A First In Human Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Single Oral Doses Of PF-06372865HealthyNCT01951144Pfizer45
Completed
Phase 1
A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Oral Doses Of PF-06273340PAINNCT01601834Pfizer20
Completed
Phase 1
Study to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519DyslipidemiaNCT03210649Chong Kun Dang Pharmaceutical18