Pharmacokinetics and Safety of the Co-administration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Healthy Chinese Subjects

NCT02534870 | Completed Phase 1

• 1 other identifier: M13-769
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the pharmacokinetics and safety of multiple oral doses of ABT-450/ritonavir/ABT-267 and ABT-333 when co-administered under non-fasting conditions in healthy Chinese adult participants.

Conditions

Healthy Volunteer

Keywords

Volunteer

Outcome Measures

Primary Outcomes (17)

• Maximum Plasma Concentration (Cmax) of ABT-450

  Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval.

  Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14; and 36, 48, and 72 hours after the morning dose on Study Day 14

• Maximum Plasma Concentration (Cmax) of ABT-267

  Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval.

  Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14; and 36, 48, and 72 hours after the morning dose on Study Day 14

• Maximum Plasma Concentration (Cmax) of ABT-333

  Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval.

  Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14; and 36, 48, and 72 hours after the morning dose on Study Day 14

• Maximum Plasma Concentration (Cmax) of Ritonavir

  Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval.

  Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14; and 36, 48, and 72 hours after the morning dose on Study Day 14

• Time to Maximum Plasma Concentration (Tmax) of ABT-450

  Tmax is the time it takes for a drug to achieve Cmax.

  Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14; and 36, 48, and 72 hours after the morning dose on Study Day 14

• Time to Maximum Plasma Concentration (Tmax) of ABT-267

  Tmax is the time it takes for a drug to achieve Cmax.

  Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14; and 36, 48, and 72 hours after the morning dose on Study Day 14

• Time to Maximum Plasma Concentration (Tmax) of ABT-333

  Tmax is the time it takes for a drug to achieve Cmax.

  Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14; and 36, 48, and 72 hours after the morning dose on Study Day 14

• Time to Maximum Plasma Concentration (Tmax) of Ritonavir

  Tmax is the time it takes for a drug to achieve Cmax.

  Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14; and 36, 48, and 72 hours after the morning dose on Study Day 14

• Trough Concentration (Ctrough) of ABT-450

  Ctrough is the lowest concentration of a drug in the blood after administration in a dosing interval.

  Prior to the morning dose on Study Days 7, 9, 11, 13 and 14; 24 hours after Day 14 dose

• Trough Concentration (Ctrough) of ABT-267

  Ctrough is the lowest concentration of a drug in the blood after administration in a dosing interval.

  Prior to the morning dose on Study Days 7, 9, 11, 13 and 14; 24 hours after Day 14 dose

• Trough Concentration (Ctrough) of ABT-333

  Ctrough is the lowest concentration of a drug in the blood after administration in a dosing interval.

  Prior to the morning dose on Study Days 7, 9, 11, 13 and 14; 24 hours after Day 14 dose

• Trough Concentration (Ctrough) of Ritonavir

  Ctrough is the lowest concentration of a drug in the blood after administration in a dosing interval.

  Prior to the morning dose on Study Days 7, 9, 11, 13 and 14; 24 hours after Day 14 dose

• Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-450

  Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14

• Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of Ritonavir

  Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14

• Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-267

  Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14

• Area Under the Plasma Concentration-time Curve From 0 to 12 Hours (AUC12) Post-dose of ABT-333

  Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, and 12 hours after the morning dose on Study Days 1 and 14

• Number of participants with adverse events

  Daily for approximately 20 days

Study Arms (1)

ABT-450/r/ABT-267 + ABT-333

EXPERIMENTAL

ABT-450/r/ABT-267 will be administered once daily in the morning and ABT-333 will be administered in the morning and evening for 14 days.

Drug: ABT-450/r/ABT-267; Drug: ABT-333

Interventions

ABT-450/r/ABT-267 DRUG

Tablet

Also known as: Paritaprevir/Ritonavir/Ombitasvir

ABT-450/r/ABT-267 + ABT-333

ABT-333 DRUG

Tablet

Also known as: Dasabuvir

ABT-450/r/ABT-267 + ABT-333

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• If female, participant must be either postmenopausal for at least 2 years, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control with male partner(s): total abstinence from sexual intercourse as the preferred life style of the subject, periodic abstinence is not acceptable; vasectomized partner(s); hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration; intrauterine device (IUD); or double-barrier method (condoms, contraceptive sponge, or diaphragm with spermicidal jellies or creams)
• Hormonal contraceptives, including but not limited to oral, topical, injectable or implantable varieties, may not be used during the study.
• If male, the participant must be surgically sterile or practicing at least 1 of the following methods of contraception, and refrain from sperm donation, from initial study drug administration until 90 days after the last dose of study drug: partner(s) using an IUD; partner(s) using oral, injected, intravaginal, or implanted methods of hormonal contraceptives; participant and/or partner(s) using double-barrier method (condoms, contraceptive sponge, diaphragm with spermicidal jellies or creams, or vaginal ring); or total abstinence from sexual intercourse as the preferred life style of the subject; periodic abstinence is not acceptable
• Body Mass Index (BMI) is ≥ 18 to \< 30 kg/m\^2.
• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, a 12-lead electrocardiogram (ECG) and chest x-ray (CXR).

You may not qualify if:

• History of epilepsy, any clinically significant cardiovascular, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disease or disorder.
• Clinically significant abnormal ECG: ECG with QT interval corrected for heart rate using Fridericia's correction formula (QTcF) \> 450 msec in females and \> 430 msec in males, or ECG with second or third degree atrioventricular block.
• Previous exposure to more than a single dose of ABT-450/r/ABT-267, or ABT-333 within the past 12 weeks, or previous participation in this study.
• Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-450, ritonavir, ABT-267, or ABT-333.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Site Reference ID/Investigator# 137655

Shanghai, 200031, China

Location

Related Publications (1)

• Zha J, Ding B, Wang H, Zhao W, Yu C, Alves K, Mobashery N, Luo Y, Menon RM. Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients. Eur J Drug Metab Pharmacokinet. 2019 Feb;44(1):43-52. doi: 10.1007/s13318-018-0492-8.

  PMID: 29909549 DERIVED

MeSH Terms

Interventions

paritaprevir; dasabuvir

Study Officials

• Yan Luo, MD

  AbbVie

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: August 28, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 19, 2015

Record last verified: 2015-10

Locations

CN (1)