HealthyPhase 1NCT01091649
Study in Healthy Adults to Evaluate the Bioavailability of Two Test Tablet Formulations of ABT-450
A Phase 1 study testing ABT-450 and ritonavir in people with Healthy, run by Abbott at 1 site in United States.
Trial summary
The objective of this study is to assess the relative bioavailability of two test tablet formulations of ABT-450 as compared to the ABT-450 hard gelatin capsule formulation as a reference. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ABT-450 and ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Apr 2010
- 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
- Positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-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 that are considered clinically significant by the investigator
- Pregnant or breastfeeding female; requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis
- Previous exposure to ABT-450
Trial locations and contacts
1 site in 1 country.
United States1 site
Site Reference ID/Investigator# 27781
Waukegan, Illinois, 60085
About this study
Official title: An Open-label, Randomized, Crossover Study to Evaluate the Bioavailability of Two Candidate Tablet Formulations of ABT-450 With Reference to the Hard Gelatin Capsule Formulation
The objective of this study is to assess the relative bioavailability of two test tablet formulations of ABT-450 as compared to the ABT-450 hard gelatin capsule formulation as a reference.
Read the detailed description
This is a two part study. Part 1 is a single dose, three period, complete crossover study in approximately 21 subjects. Part 2 is a single dose, two period, complete crossover study in approximately 20 subjects.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-450Drug
Low dose ABT-450 / ritonavir see Arm Description for more information
ritonavirDrug
Also called ABT-538, ritonavir, Norvir
ritonavir see Arm Description for more information
ABT-450Drug
High dose ABT-450 / ritonavir See Arm Description for more information
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Low dose ABT-450 capsule and ritonavir capsules (reference). Receives: Drug: ABT-450; Drug: ritonavir |
| B | Active comparator | Low dose ABT-450 SDD Tablet Form 1 and ritonavir capsules (test 1) Receives: Drug: ABT-450; Drug: ritonavir |
| C | Active comparator | Low dose ABT-450 SDD Tablet Form 2 and ritonavir capsules (test 2). Receives: Drug: ABT-450; Drug: ritonavir |
| D | Active comparator | High dose ABT-450 capsule and ritonavir capsules (reference). Receives: Drug: ritonavir; Drug: ABT-450 |
| E | Active comparator | High dose ABT-450 SDD Tablet Form 1 or 2 and ritonavir capsule (test) Receives: Drug: ritonavir; Drug: ABT-450 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pharmacokinetics of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at low ABT-450/ritonavir
Measured: 72 hrs post dose
Assessment of Pharmacokinetics of the selected ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at high ABT-450/ritonavir
Measured: 72 hrs post dose
Secondary outcomes (1)
To tabulate treatment emergent adverse events of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir
Measured: Through 30 days post last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Adebayo Lawal, M.D., Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091649
- Sponsor's protocol ID
- M10-797
- Status last verified
- Sep 2010
- First submitted
- 26 Feb 2010
- Last updated
- 21 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Crossover Study to Evaluate the Bioavailability of Two Candidate Tablet Formulations of ABT-450 With Reference to the Hard Gelatin Capsule Formulation
- ClinicalTrials.gov ID
- NCT01091649
- Acronym / sponsor ID
- M10-797
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 24 Mar 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.
The objective of this study is to assess the relative bioavailability of two test tablet formulations of ABT-450 as compared to the ABT-450 hard gelatin capsule formulation as a reference.
Detailed description
This is a two part study. Part 1 is a single dose, three period, complete crossover study in approximately 21 subjects. Part 2 is a single dose, two period, complete crossover study in approximately 20 subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: ABT-450, Drug: ritonavirLow dose ABT-450 capsule and ritonavir capsules (reference). |
| B | Active comparator | Drug: ABT-450, Drug: ritonavirLow dose ABT-450 SDD Tablet Form 1 and ritonavir capsules (test 1) |
| C | Active comparator | Drug: ABT-450, Drug: ritonavirLow dose ABT-450 SDD Tablet Form 2 and ritonavir capsules (test 2). |
| D | Active comparator | Drug: ritonavir, Drug: ABT-450High dose ABT-450 capsule and ritonavir capsules (reference). |
| E | Active comparator | Drug: ritonavir, Drug: ABT-450High dose ABT-450 SDD Tablet Form 1 or 2 and ritonavir capsule (test) |
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 (6 listed)
- Positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-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 that are considered clinically significant by the investigator
- Pregnant or breastfeeding female; requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis
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-450Low dose ABT-450 / ritonavir see Arm Description for more information | Drug | A, B, C |
| ritonavirAlso: ABT-538, ritonavir, Norvirritonavir see Arm Description for more information | Drug | A, B, C, D, E |
| ABT-450High dose ABT-450 / ritonavir See Arm Description for more information | Drug | D, E |
Primary outcome
Assessment of Pharmacokinetics of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at low ABT-450/ritonavir
Time frame: 72 hrs post dose
Assessment of Pharmacokinetics of the selected ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at high ABT-450/ritonavir
Time frame: 72 hrs post dose
1 secondary outcome
To tabulate treatment emergent adverse events of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir
Time frame: Through 30 days post last dose.
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 21 Dec 2010.
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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 Lawal, M.D. 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 Healthy, run by Abbott 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 6 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 21 Dec 2010. 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. 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?
Assessment of Pharmacokinetics of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at low ABT-450/ritonavir (time frame: 72 hrs post dose). 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?
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 21 Dec 2010.