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

Study Overview
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Brief Summary
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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.

Official Title
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Multiple-Dose Pharmacokinetics, Safety and Tolerability of the Co-administration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Healthy Chinese Subjects

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: ABT-450/r/ABT-267
* Drug: ABT-333


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must be Chinese (i.e., of Chinese ancestry). 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). Exclusion Criteria: Use of any medications (prescription and over-the-counter), vitamins and/or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-450/r/ABT-267 + ABT-333<br>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<br>* Tablet<br>* Other names: Paritaprevir/Ritonavir/Ombitasvir;Drug: ABT-333<br>* Tablet<br>* Other names: Dasabuvir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Volunteer