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

NCT01590901 | Completed Phase 1 DMC

• 1 other identifier: 009-11-803-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Pharmacokinetics; Probucol; healthy male subjects

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameters

  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).

  Day 1, 3, 5, 7, 9, 11, 12, 13, 14

Study Arms (1)

probucol in healthy male subjects

OTHER

multiple oral doses of probucol in single group of healthy male subjects

Drug: Probucol

Interventions

Probucol DRUG

250mg (1 tablet) bid. p.o for 14 consecutive days

Also known as: Lorelco

probucol in healthy male subjects

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese.
• Gender: Male.
• Age 20 to 40 years, (at time of informed consent).
• Body mass index \[BMI, body weight (kg) / height (m)2\] between 19 and 26 kg/m2, inclusive.
• Nonsmokers (or former smokers): Urinary cotinine level satisfying the criteria for a nonsmoker established by the trial site (at time of screening examination).
• 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.

You may not qualify if:

• Subjects with hypersensitivity or a history of hypersensitivity to any drug (any prescription or over-the-counter \[OTC\] drug)
• 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.
• 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)
• Subjects with alcohol or drug dependence or a history of drug abuse
• Subjects who have a positive result in an infectious disease test or urine drug test (at time of screening examination)
• 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)
• Use of any other investigational drug within 16 weeks prior to scheduled IMP administration in the present trial
• 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

Sponsors & Collaborators

• Otsuka Beijing Research Institute: lead

Study Sites (1)

Clinical Pharmacology Research Center, Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Interventions

Probucol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Pei Hu, PHD

  Clinical Pharmacology Research Center of Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: May 3, 2012
• Study Start: February 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: January 1, 2013
• Last Updated: June 5, 2013

Record last verified: 2013-06

Locations

CN (1)