Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
NCT ID:
NCT01524406
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.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
55 Years
Study:
NCT01524406
Study Brief:
Protocol Section:
NCT01524406