AzTrials
AzTrials

Healthy VolunteerPhase 1NCT02534870

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

A Phase 1 study testing ABT-450/r/ABT-267 and ABT-333 in people with Healthy Volunteer, run by AbbVie at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
ABT-450/r/ABT-267 and ABT-333
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
Sep 2015to Sep 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Site Reference ID/Investigator# 137655

    Shanghai, 200031

Other trials in China

About this study

Official 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

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.

Being tested
ABT-450/r/ABT-267, ABT-333
Keywords
Volunteer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-450/r/ABT-267Drug

    Also called Paritaprevir/Ritonavir/Ombitasvir

    Tablet

  • ABT-333Drug

    Also called Dasabuvir

    Tablet

Study groups in NCT02534870
Study groupRoleWhat they receive
ABT-450/r/ABT-267 + ABT-333ExperimentalABT-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.
Receives: Drug: ABT-450/r/ABT-267; Drug: ABT-333

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. 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.

    Measured: 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

  3. 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.

    Measured: 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

  4. Maximum Plasma Concentration (Cmax) of Ritonavir

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

    Measured: 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

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

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

    Measured: 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

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

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

    Measured: 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

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

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

    Measured: 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

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

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

    Measured: 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

  9. Trough Concentration (Ctrough) of ABT-450

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

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

  10. Trough Concentration (Ctrough) of ABT-267

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

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

  11. Trough Concentration (Ctrough) of ABT-333

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

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

  12. Trough Concentration (Ctrough) of Ritonavir

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

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

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Daily for approximately 20 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02534870
Sponsor's protocol ID
M13-769
Status last verified
Oct 2015
First submitted
26 Aug 2015
Last updated
19 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29909549

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABT-450/r/ABT-267 and ABT-333 in people with Healthy Volunteer, run by AbbVie at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02534870, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in