Safety, Tolerability and Pharmacokinetics of SP-8203

• Status: Completed
• Trial end date: 2015-03-11
• Target enrollment: 0
• Participant gender: All

Summary

Phase I study in health volunteers to assess the safety, tolerability and pharmacokinetics of escalating single doses and multiple doses of SP-8203

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shin Poong Pharmaceutical Co. Ltd.
• Treatments: Otaplimastat

Criteria

Inclusion Criteria:

1. Male or female ages of 20 and 45 years, inclusive.

2. Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control, or be surgically sterile or post-menopausal.

3. Males must be agree to practice an medically acceptable method of birth control and will not donate sperm during the study.

4. Subject's body mass index (BMI) is ≥ 18 and ≤ 32, inclusive.

5. Subject does not smoke and has not smoked or used nicotine-containing products for at least 6 continuous months prior to the first dose.

6. Subject has adequate venous access for repeated venipuncture.

7. Subject has hemoglobin >/= 11.5 g/dL.

8. Subject agrees to abstain from taking any dietary supplements or non-prescription drugs (except for multivitamins or as otherwise authorized by the Investigator and Medical Monitor) for 14 days prior to CRU admission through discharge.

9. Subject agrees to abstain from consuming alcohol-containing beverages for 3 days prior to CRU admission through discharge.

10. Subject agrees to abstain from consuming caffeine- or chocolate-containing products from CRU admission through discharge.

11. Subject is in general good health based on medical history and clinically acceptable results on the following assessments: physical examination, vital signs, 12 lead ECG, clinical chemistry, hematology/coagulation, and urinalysis.

12. Seated systolic blood pressure must be >90 mmHg and >140 mmHg and seated diastolic blood pressure must be >50 mmHg and >90 mmHg at Screening and Baseline.

13. Subject voluntarily provides written informed consent.

Exclusion Criteria:

1. Subject has a history or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.

2. History of anaphylaxis, a documented hypersensitivity reaction, or a clinically important idiosyncratic reaction to any drug.

3. Predisposing condition that could interfere with the distribution, metabolism, or excretion of drugs or any condition that may confound the PK analyses.

4. Positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C virus.

5. Have chronic Qt prolongation syndrome (i.e. Qt > 450 ms for males and >470 ms for females) in repeated EKG measurements.

6. Drugs or substances known to inhibit or induce cytochrome 2D6 (CYP) enzymes within 28 days prior to the first dose and throughout the study.

7. Recent (2-year) history or evidence of alcoholism or drug abuse.

8. Positive for alcohol or drugs of abuse at the Screening Visit or upon admission to the CRU.

9. Special diet during the 28 days prior to the first dose (eg, Atkins, South Beach, or any other high protein / high fat diets).

10. Subject reports difficulty fasting or consuming standardized meals.

11. Subject has donated blood or plasma (eg. Plasmapheresis) within 28 days prior to the first dose of study medication.

12. Participated in another clinical trial within 90 days prior to dosing.

13. History of malignancy within the past 5 years, with the exception of successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin and/or localized carcinoma in situ of the cervix.

14. Investigator's decision to exclude for other reason.