Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects

• Sponsor: Otsuka Beijing Research Institute (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01590901
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 11
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The Objectives of this study is to evaluate the pharmacokinetics and safety of multiple oral doses of probucol in healthy male subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Probucol	Phase 1

Detailed Description

This is a single dose, single period, multiple administration, open-labeled trial in one investigation center.

The screening examination will be completed from Day -14 to Day -2 before investigational medicinal product (IMP) administration. The subjects will be hospitalized on Day -1. From Day 1 (the next day), the subjects will receive probucol twice daily (BID). for 14 consecutive days. On Day 18, the subjects can be discharged after the safety evaluation. The follow-up visit will occur on Day 6, 9, 12, 15, 19, 27 (totally 41 days) after the final dosing day.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: probucol in healthy male subjects multiple oral doses of probucol in single group of healthy male subjects	Drug: Probucol; 250mg (1 tablet) bid. p.o for 14 consecutive days; Other Names: Lorelco

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetic parameters [Day 1, 3, 5, 7, 9, 11, 12, 13, 14]

   Pharmacokinetic parameters: Day 1 (Plasma PK parameters over the 24h dosing period)： Cmax, Cmax1, Cmax2, tmax1, tmax2, AUC (0-10)h, AUC (10-24)h, AUC24h, C24h; Day3，5，7，9，11，12，13：C24h; Day 14： Cmax, Cmax1, Cmax2, tmax1, tmax2, AUC (0-10)h, AUC (10-24)h, AUC24h, C24h, Clast, tlast, t1/2,z,Lambdaz, DF, CL/F, Vz/F, AUC_%Extrap; Accumulation evaluation parameters: Rpred, R14,ac(AUC24h), R14,ac(Cmax), R14,ac(C24h), R14,ac[AUC(0-10h)], R14,ac[AUC(10-24h)], R14,ac(Cmax1), R14,ac(Cmax2).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Chinese.

2. Gender: Male.

3. Age 20 to 40 years, (at time of informed consent).

4. Body mass index [BMI, body weight (kg) / height (m)2] between 19 and 26 kg/m2, inclusive.

5. Nonsmokers (or former smokers): Urinary cotinine level satisfying the criteria for a nonsmoker established by the trial site (at time of screening examination).

6. Subjects judged by the investigator to be healthy based on the medical history, physical examination, vital signs, 12 lead ECG, the results of serological test (HIV/HCV Ab, HBsAg and Syphilis Ab) and clinical laboratory tests, etc.

Exclusion Criteria:

1. Subjects with hypersensitivity or a history of hypersensitivity to any drug (any prescription or over-the-counter [OTC] drug)

2. Subjects who meet any of the following lipid criteria in the fasting state (at time of screening examination)

• LDL-C: ≥ 140 mg/dL

• TC: ≥ 220 mg/dL

• HDL-C: < 40 mg/dL

• TG: ≥ 150 mg/dL

• LDL-C value will be directly measured or calculated by the Friedewald formula. Friedewald Formula: LDL-C = TC - HDL-C - TG/5 (When TG value is less than 400 mg/dL) LDL-C value will be directly measured when TG value is 400 mg/dL or greater.

1. Subjects with electrocardiogram (ECG) results showing AV block or with both QTc and QRS width outside the standard values of the ECG laboratory (at time of screening examination)

2. Subjects with alcohol or drug dependence or a history of drug abuse

3. Subjects who have a positive result in an infectious disease test or urine drug test (at time of screening examination)

4. Use of any of the following within the specified period prior to scheduled investigational medicinal product (IMP) administration

• All other prescription and OTC drugs (within 2 weeks prior to scheduled IMP administration)

• Alcohol and caffeine-containing products (within 1 week prior to scheduled IMP administration)

1. Use of any other investigational drug within 16 weeks prior to scheduled IMP administration in the present trial

2. Plasmapheresis or plateletpheresis within 2 weeks or whole blood collection (blood donation, etc) cumulatively exceeding 200 mL within 4 weeks, 400 mL within 12 weeks, or 1200 mL within 1 year prior to scheduled IMP administration

3. Subjects whose body weight is less than 50 kg (at time of screening examination)

4. Subjects who are scheduled for examination or treatment at any other hospital or clinic during the trial period

5. Subjects otherwise judged by the investigator or sub investigator to be inappropriate for inclusion in the trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology Research Center, Peking Union Medical College Hospital	Beijing		China

Sponsors and Collaborators

• Otsuka Beijing Research Institute

Investigators

• Principal Investigator: Pei Hu, PHD, Clinical Pharmacology Research Center of Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Otsuka Beijing Research Institute
• ClinicalTrials.gov Identifier: NCT01590901
• Other Study ID Numbers: 009-11-803-01
• First Posted: May 3, 2012
• Last Update Posted: Jun 5, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Otsuka Beijing Research Institute: Pharmacokinetics; Probucol; healthy male subjects
• Additional relevant MeSH terms: Probucol

Study Results

No Results Posted as of Jun 5, 2013