A Study to Access Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD) of Orally Administered GCC-4401C in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

The purpose of this study is to evaluate the safety, tolerability and Pharmacokinetics/Pharmacodynamics of multiple doses of GCC-4401C in healthy male subjects.

Key facts

Study ID

NCT01954238

Run by

Green Cross Corporation

People needed

46

Starts

2013-08-01

Expected to finish

2014-05-01

Last updated by the study team

2014-12-23

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Subject voluntarily has agreed to participate in this study and signed an Institutional Review Board (IRB)-approved informed consent before any of the Screening procedures will be performed.
• Males between 18 to 45 years of age, inclusive, at Screening.
• Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past month prior to screening) and by urine cotinine concentration (< 400 ng/mL) at Screening.
• Body mass index (BMI) between 18.5 and 28.0 kg/m2 at Screening.
• Healthy, determined by pre-study medical evaluation and Investigator/designee discretion (medical history, physical examination, vital signs, ECG, and clinical laboratory evaluations).

You may not qualify if…

• Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the Investigator/designee.
• Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
• Have any of the following, which may put them at increased risk with anticoagulant use: family history or personal history of bleeding disorders or diseases/syndromes that can either alter or increase the propensity for bleeding; any other contraindication to anticoagulant treatment, or increased bleeding risk, as judged by the Investigator.
• Are considering or scheduled to undergo any surgical procedure during the study.
• Any concurrent disease or condition that, in the opinion of the Investigator/designee, would make the subject unsuitable for participation in the clinical study.
• Fecal occult blood positive test at screening and admission.
• Subject has history of alcohol and/or illicit drug abuse within one year of the Screening visit.
• Positive Screening test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody.
• Positive alcohol breathalyzer test at Screening or Day -1.
• Positive urine drug test (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids, etc.) at Screening or Day -1.
• Subject unwilling to avoid consumption of coffee and caffeine containing beverages within 48 hours prior to Day -1 until discharge from the clinical site.
• Subject unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to Day -1 until discharge from the clinical site.
• Donation of blood (> 500 mL) or blood products within 2 months (56 days) prior to Day -1.
• Use of over-the-counter (OTC) medications, prescription medications, or herbal remedies from 14 days or 5 time their half-lives whatever is more, prior to Day -1 and vitamin from 7 days prior to Day -1, until End-of-Study. By exception, acetaminophen 1000 mg per day is permitted.
• Use of any drugs that induce or inhibit cytochrome P450 or P-glycoprotein within 30 days prior to dosing.
• Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade, or other products containing grapefruit or Seville oranges within 7 days of dosing.
• Use of an investigational drug within 30 days prior to Day 1.
• Unwilling to abstain from vigorous exercise from 48 hours prior to Day -1 until End-of-Study.
• Subject has a history of hypersensitivity to the investigational medicinal products (IMPs) or any of the excipients or to medicinal products with similar chemical structures.
• Planning to father a child or donate sperm during the study and within 3 months following dosing.
• Subject does not have veins suitable for cannulation or multiple venipunctures.
• Subject is unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study.
• Subject is unlikely to comply with the protocol requirements, instructions and study related restrictions; e.g., uncooperative attitude, inability to return for Follow-up visits and improbability of completing the clinical study.
• Subject has previously been enrolled in this clinical study.
• Subjects involved in the planning or conduct of this clinical study.

Where it is running

• PAREXEL Internatonal — Early Phase Clinical Unit _Los Angeles, California, United States

Full record on ClinicalTrials.gov

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