HCV InfectionPhase 1NCT01181427
Study of ABT-267 in Both Healthy Volunteers and Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
A Phase 1 study testing ABT-267, Blood Sample Collection and Cytochrome P450 inhibitor in people with HCV Infection, run by Abbott at 3 sites in United States.
Trial summary
Study of ABT-267 in both healthy volunteers and Hepatitis C virus (HCV) genotype 1 infected subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HCV Infection
- What is being tested?
- ABT-267, Blood Sample Collection and Cytochrome P450 inhibitor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2010to Jan 2012
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Main Selection Criteria for Healthy Volunteers:
- Subject has provided written consent.
- Subject is in general good health.
- Females must be post-menopausal for at least 2 years or surgically sterile.
- Females must not be pregnant or breast-feeding. If male, subject is surgically sterile or practicing specific forms of birth control.
- Main Selection Criteria for HCV Genotype 1-infected Volunteers:
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- Subject has provided written consent.
- Subject has chronic HCV genotype 1 infection at screening.
- Liver biopsy within 3 years with histology.
- Females must be post-menopausal for at least 2 years or surgically sterile.
- Females must not be pregnant or breast-feeding. If male, subject is surgically sterile or practicing specific forms of birth control.
- Subject is in general good health, as perceived by the investigator, other than HCV infection.
- Main Selection Criteria for Volunteers in the Resistance Monitoring Portion of the Study:
- Subject has provided written consent, has received at least one dose of ABT-267 or placebo in the study, and is considered suitable by the investigator to participate.
Who cannot join
- Main Exclusion Criteria for Healthy Volunteers:
- Positive test for HAV IgM, HBsAg, HCV Ab or HIV Ab.
- 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.
- Abnormal screening laboratory results.
- Significant sensitivity to any drug.
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- Requirement for any over the counter and/or prescription medication, vitamins and/or herbal supplements on a regular basis.
- Main Exclusion Criteria for HCV Genotype 1-infected Volunteers:
- Significant sensitivity to any drug.
- Positive HBsAg, HAV-IgM, and HIV Ab. Use of CYP enzyme inducers or inhibitors within 1 month of dosing.
- Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid disease (except hypothyroidism on stable thyroid replacement therapy), or any uncontrolled medical illness or psychiatric disorder.
- Use of any medications (prescription and over-the counter) within 2 weeks prior to study drug dosing without prior approval by the Abbott Medical Monitor.
- Use of any vitamins or herbal supplements within 2 weeks prior to study drug dosing.
- Prior treatment with any investigational or commercially available anti-HCV agents.
- Abnormal screening laboratory results.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Site Reference ID/Investigator# 42708
Orlando, Florida, 32809
Site Reference ID/Investigator# 42707
San Antonio, Texas, 78215
Site Reference ID/Investigator# 43322
Waukegan, Illinois, 60085
About this study
Official title: A Blinded, Randomized, Placebo-Controlled Study in Healthy and HCV Genotype 1-infected Adults, to Evaluate the Safety, Tolerability, Antiviral Activity, Pharmacokinetics (Including the Effect of Food) and Resistance Profile of Single and Multiple Doses of ABT-267
Study of ABT-267 in both healthy volunteers and Hepatitis C virus (HCV) genotype 1 infected subjects.
- Conditions
- HCV Infection
- Being tested
- ABT-267, Placebo, Blood Sample Collection, Cytochrome P450 inhibitor
- 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-267Drug
See arm description
PlaceboDrug
See arms description
Blood Sample CollectionProcedure or surgery
See arm description
Cytochrome P450 inhibitorDrug
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose (SAD) | Placebo comparator | Healthy volunteers, receiving single ascending doses of ABT-267 or placebo. Receives: Drug: ABT-267; Drug: Placebo |
| Multiple Ascending Dose (MAD) | Placebo comparator | Healthy volunteers, receiving multiple ascending doses of ABT-267 or placebo, OR, multiple doses of ABT-267 + single dose of a Cytochrome P450 inhibitor or placebo + single dose of a Cytochrome P450 inhibitor. Receives: Drug: ABT-267; Drug: Placebo; Drug: Cytochrome P450 inhibitor |
| Food Effect (FE) | Active comparator | Healthy volunteers, receiving ABT-267, multi-dose, food effect. Receives: Drug: ABT-267 |
| Antiviral Activity | Placebo comparator | HCV genotype 1-infected treatment naïve subjects receiving multiple ascending doses of ABT-267 or placebo monotherapy for 3 days. Receives: Drug: ABT-267; Drug: Placebo |
| Resistance Monitoring | No intervention | HCV genotype 1-infected treatment naïve subjects, receiving at least one dose of ABT-267 or placebo in the "Antiviral Activity" arm, follow-up to monitor resistance developed to ABT-267, no treatment and only blood samples will be collected Receives: Procedure: Blood Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.
Measured: Up to 15 days or less
Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, vital signs, ECGs, continuous cardiac monitoring, and clinical lab results (including chemistry, hematology and urine).
Measured: Update to 20 days or less
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2011
- Study completionJan 2012
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.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Campbell, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181427
- Sponsor's protocol ID
- M12-116
- Status last verified
- Jan 2012
- First submitted
- 12 Aug 2010
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Krishnan P, Beyer J, Mistry N, Koev G, Reisch T, DeGoey D, Kati W, Campbell A, Williams L, Xie W, Setze C, Molla A, Collins C, Pilot-Matias T. In vitro and in vivo antiviral activity and resistance profile of ombitasvir, an inhibitor of hepatitis C virus NS5A. Antimicrob Agents Chemother. 2015 Feb;59(2):979-87. doi: 10.1128/AAC.04226-14. Epub 2014 Dec 1.
PubMed 25451055
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded, Randomized, Placebo-Controlled Study in Healthy and HCV Genotype 1-infected Adults, to Evaluate the Safety, Tolerability, Antiviral Activity, Pharmacokinetics (Including the Effect of Food) and Resistance Profile of Single and Multiple Doses of ABT-267
- ClinicalTrials.gov ID
- NCT01181427
- Acronym / sponsor ID
- M12-116
- Conditions
- HCV Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 13 Aug 2010 (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.
Study of ABT-267 in both healthy volunteers and Hepatitis C virus (HCV) genotype 1 infected subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (SAD) | Placebo comparator | Drug: ABT-267, Drug: PlaceboHealthy volunteers, receiving single ascending doses of ABT-267 or placebo. |
| Multiple Ascending Dose (MAD) | Placebo comparator | Drug: ABT-267, Drug: Placebo, Drug: Cytochrome P450 inhibitorHealthy volunteers, receiving multiple ascending doses of ABT-267 or placebo, OR, multiple doses of ABT-267 + single dose of a Cytochrome P450 inhibitor or placebo + single dose of a Cytochrome P450 inhibitor. |
| Food Effect (FE) | Active comparator | Drug: ABT-267Healthy volunteers, receiving ABT-267, multi-dose, food effect. |
| Antiviral Activity | Placebo comparator | Drug: ABT-267, Drug: PlaceboHCV genotype 1-infected treatment naïve subjects receiving multiple ascending doses of ABT-267 or placebo monotherapy for 3 days. |
| Resistance Monitoring | No intervention | Procedure: Blood Sample CollectionHCV genotype 1-infected treatment naïve subjects, receiving at least one dose of ABT-267 or placebo in the "Antiviral Activity" arm, follow-up to monitor resistance developed to ABT-267, no treatment and only blood samples will be collected |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subject has provided written consent.
- Subject is in general good health.
- Females must be post-menopausal for at least 2 years or surgically sterile.
- Females must not be pregnant or breast-feeding. If male, subject is surgically sterile or practicing specific forms of birth control.
- Subject has provided written consent.
Key exclusion criteria (15 listed)
- Positive test for HAV IgM, HBsAg, HCV Ab or HIV Ab.
- 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.
- Abnormal screening laboratory results.
- Significant sensitivity to any drug.
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-267See arm description | Drug | Antiviral Activity, Food Effect (FE), Multiple Ascending Dose (MAD), Single Ascending Dose (SAD) |
| PlaceboSee arms description | Drug | Antiviral Activity, Multiple Ascending Dose (MAD), Single Ascending Dose (SAD) |
| Blood Sample CollectionSee arm description | Procedure or surgery | Resistance Monitoring |
| Cytochrome P450 inhibitorSee arm description | Drug | Multiple Ascending Dose (MAD) |
Primary outcome
Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.
Time frame: Up to 15 days or less
Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, vital signs, ECGs, continuous cardiac monitoring, and clinical lab results (including chemistry, hematology and urine).
Time frame: Update to 20 days or less
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 24 Jan 2012.
- Derived from this study: PubMed 25451055Krishnan P, Beyer J, Mistry N, Koev G, Reisch T, DeGoey D, Kati W, Campbell A, Williams L, Xie W, Setze C, Molla A, Collins C, Pilot-Matias T. In vitro and in vivo antiviral activity and resistance profile of ombitasvir, an inhibitor of hepatitis C virus NS5A. Antimicrob Agents Chemother. 2015 Feb;59(2):979-87. doi: 10.1128/AAC.04226-14. Epub 2014 Dec 1.
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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.
Andrew Campbell, MD study director
Abbott
3 sites 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-267, Blood Sample Collection and Cytochrome P450 inhibitor in people with HCV Infection, run by Abbott at 3 sites 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 14 inclusion and 15 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 24 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline. (time frame: Up to 15 days or less). 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 NCT01181427, 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 24 Jan 2012.