Healthy Volunteer
Conditions
Keywords
Volunteer
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.
Interventions
Tablet
DRUGABT-333
Tablet
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) 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; 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. |
| Maximum Plasma Concentration (Cmax) 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; 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. |
| Maximum Plasma Concentration (Cmax) of ABT-333 | 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. |
| Maximum Plasma Concentration (Cmax) 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; 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. |
| Time to Maximum Plasma Concentration (Tmax) 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; 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. |
| Time to Maximum Plasma Concentration (Tmax) 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; 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. |
| Time to Maximum Plasma Concentration (Tmax) of ABT-333 | 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. |
| Time to Maximum Plasma Concentration (Tmax) 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; 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. |
| Trough Concentration (Ctrough) of ABT-450 | 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. |
| Trough Concentration (Ctrough) of ABT-267 | 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. |
| Trough Concentration (Ctrough) of ABT-333 | 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. |
| Trough Concentration (Ctrough) of Ritonavir | 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. |
| 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 | — |
Countries
China
Outcome results
None listed