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NCT Number: NCT02534870

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 137655

Shanghai, 200031, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABT-450/r/ABT-267

Drug

Tablet

Other names: Paritaprevir/Ritonavir/Ombitasvir

ABT-333

Drug

Tablet

Other names: Dasabuvir

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of ABT-450

    Time frame: 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

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

  2. Maximum Plasma Concentration (Cmax) of ABT-267

    Time frame: 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

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

  3. Maximum Plasma Concentration (Cmax) of ABT-333

    Time frame: 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

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

  4. Maximum Plasma Concentration (Cmax) of Ritonavir

    Time frame: 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

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

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

    Time frame: 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

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

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

    Time frame: 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

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

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

    Time frame: 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

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

  8. Time to Maximum Plasma Concentration (Tmax) of Ritonavir

    Time frame: 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

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

  9. Trough Concentration (Ctrough) of ABT-450

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

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

  10. Trough Concentration (Ctrough) of ABT-267

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

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

  11. Trough Concentration (Ctrough) of ABT-333

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

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

  12. Trough Concentration (Ctrough) of Ritonavir

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

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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

  17. Number of participants with adverse events

    Time frame: Daily for approximately 20 days

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 28, 2015
Registry last updated
Oct 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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