HCV InfectionPhase 1NCT00850044
Safety, Tolerability and PK Study of Single Doses of ABT-450 With and Without Ritonavir to Treat Hepatitis C Virus (HCV) Genotype 1
A Phase 1 study testing ABT-450 and ritonavir in people with HCV Infection, run by AbbVie at 1 site in United States.
Trial summary
The purpose of this study is to determine the pharmacokinetic and safety profiles of an experimental HCV protease inhibitor with and without ritonavir in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HCV Infection
- What is being tested?
- ABT-450 and ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jul 2009
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- overall healthy subjects
- non-childbearing potential females included
Who cannot join
- history of significant sensitivity to any drug
- positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab
- history of gastrointestinal issues or procedures
- history of seizures, diabetes or cancer (except basal cell carcinoma)
- clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder
- use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration
Show all 13Show fewer
- donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration
- abnormal screening laboratory results that are considered clinically significant by the investigator
- current enrollment in another clinical study
- previous enrollment in this study
- recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol
- pregnant or breastfeeding female
- requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis
Trial locations and contacts
1 site in 1 country.
United States1 site
Site Reference ID/Investigator# 15981
Waukegan, Illinois, 60085
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Nonfasting Study in Healthy Adults to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Single Doses of ABT-450 With and Without Ritonavir
The purpose of this study is to determine the pharmacokinetic and safety profiles of an experimental HCV protease inhibitor with and without ritonavir in healthy volunteers.
- Conditions
- HCV Infection
- Being tested
- ABT-450, ritonavir, placebo for ABT-450, Placebo for ritonavir
- Keywords
- FIH, SAD
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-450Drug
capsules,QD, one dose, see Arm Descriptions for more information
ritonavirDrug
Also called ABT-538, Norvir
capsules, QD, one dose, escalating doses, see Arm Descriptions for more information
placebo for ABT-450Drug
Also called placebo
capsules, QD, one dose
Placebo for ritonavirDrug
Also called placebo
capsules, QD, one dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | ABT-450 Receives: Drug: ABT-450 |
| 2 | Placebo comparator | Placebo for ABT-450 Receives: Drug: placebo for ABT-450 |
| 3 | Active comparator | ABT-450/ritonavir Receives: Drug: ABT-450; Drug: ritonavir |
| 4 | Placebo comparator | Placebo for ABT-450/placebo for ritonavir Receives: Drug: placebo for ABT-450; Drug: Placebo for ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (blood draws, pre- and post-dose)
Measured: 4 days
Safety and Tolerability (ECGs, AEs, vitals, physical exams, routine labs)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HCV InfectionStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Adebayo A Lawal, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850044
- Sponsor's protocol ID
- M10-749
- Status last verified
- Sep 2010
- First submitted
- 20 Feb 2009
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Menon RM, Klein CE, Podsadecki TJ, Chiu YL, Dutta S, Awni WM. Pharmacokinetics and tolerability of paritaprevir, a direct acting antiviral agent for hepatitis C virus treatment, with and without ritonavir in healthy volunteers. Br J Clin Pharmacol. 2016 May;81(5):929-40. doi: 10.1111/bcp.12873. Epub 2016 Feb 24.
PubMed 26710243
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Nonfasting Study in Healthy Adults to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Single Doses of ABT-450 With and Without Ritonavir
- ClinicalTrials.gov ID
- NCT00850044
- Acronym / sponsor ID
- M10-749
- Conditions
- HCV Infection
- Keywords
- FIH, SAD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- First posted
- 24 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the pharmacokinetic and safety profiles of an experimental HCV protease inhibitor with and without ritonavir in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: ABT-450ABT-450 |
| 2 | Placebo comparator | Drug: placebo for ABT-450Placebo for ABT-450 |
| 3 | Active comparator | Drug: ABT-450, Drug: ritonavirABT-450/ritonavir |
| 4 | Placebo comparator | Drug: placebo for ABT-450, Drug: Placebo for ritonavirPlacebo for ABT-450/placebo for ritonavir |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- overall healthy subjects
- non-childbearing potential females included
Key exclusion criteria (13 listed)
- history of significant sensitivity to any drug
- positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab
- history of gastrointestinal issues or procedures
- history of seizures, diabetes or cancer (except basal cell carcinoma)
- clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABT-450capsules,QD, one dose, see Arm Descriptions for more information | Drug | 1, 3 |
| ritonavirAlso: ABT-538, Norvircapsules, QD, one dose, escalating doses, see Arm Descriptions for more information | Drug | 3 |
| placebo for ABT-450Also: placebocapsules, QD, one dose | Drug | 2, 4 |
| Placebo for ritonavirAlso: placebocapsules, QD, one dose | Drug | 4 |
Primary outcome
Pharmacokinetics (blood draws, pre- and post-dose)
Time frame: 4 days
Safety and Tolerability (ECGs, AEs, vitals, physical exams, routine labs)
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Results publication: PubMed 26710243Menon RM, Klein CE, Podsadecki TJ, Chiu YL, Dutta S, Awni WM. Pharmacokinetics and tolerability of paritaprevir, a direct acting antiviral agent for hepatitis C virus treatment, with and without ritonavir in healthy volunteers. Br J Clin Pharmacol. 2016 May;81(5):929-40. doi: 10.1111/bcp.12873. Epub 2016 Feb 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adebayo A Lawal, MD study director
Abbott
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT-450 and ritonavir in people with HCV Infection, run by AbbVie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. 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 20 Nov 2017. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Pharmacokinetics (blood draws, pre- and post-dose) (time frame: 4 days). The study lists 2 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 NCT00850044, 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 20 Nov 2017.