Absolute BioavailabilityPhase 1NCT02052362
Bioavailability of ABT-450 and ABT-267 With Ritonavir
A Phase 1 study testing ABT-450/r/ABT-267 in people with Absolute Bioavailability, run by AbbVie at 1 site in United Kingdom.
Trial summary
A study to investigate the fraction of ABT-267 and ABT-450 absorbed by the body when given in combination with each other and Ritonavir(r). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Absolute Bioavailability
- What is being tested?
- ABT-450/r/ABT-267
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Feb 2014
- 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
- Healthy males or non-pregnant, non-lactating healthy females
- Body mass index of 18.0 to 30.0 kg/m2
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Must agree to use an adequate method of contraception
- In a condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG
Who cannot join
- Participation in a clinical research study within the previous 3 months or in an absorption, distribution, metabolism, and excretion (ADME) study within the previous 12 months
- History of any drug or alcohol abuse in the past 2 years or current smokers and those who have smoked within the last 12 months or a positive cotinine urine test at screening and admission
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- Donation or loss of greater than 550 mL of blood (including plasmapheresis) or receipt of a transfusion of any blood product within the previous 8 weeks
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies within the 14 days or any drug by injection (including vaccines) within 30 days or within 10 half-lives of the respective medication, whichever is longer, before Investigational Medical Product (IMP) administration
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Site Reference ID/Investigator# 118615
Nottingham, NG11 6JS
About this study
Official title: A Phase I, Open-Label, Single Centre Study Designed to Determine the Absolute Bioavailability of ABT-450 (150 mg) and ABT-267 (25 mg) When Administered as an Oral Co-Formulated Product With Ritonavir (100 mg), ABT 450/r/ABT 267, to Healthy Adult Subjects
A study to investigate the fraction of ABT-267 and ABT-450 absorbed by the body when given in combination with each other and Ritonavir(r).
Read the detailed description
Absolute bioavailability of ABT-267 and ABT-450 in the body when given together
- Conditions
- Absolute Bioavailability
- Being tested
- ABT-450/r/ABT-267
- Keywords
- absolute bioavailability, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-450/r/ABT-267Drug
ABT-450, ABT-267 and ritonavir
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Regimen A | Experimental | 8 Subjects in Group I - Regimen A: ABT-450/r/ABT-267 Receives: Drug: ABT-450/r/ABT-267 |
| Group 2 - Regimen B | Experimental | 8 Subjects in Group II - Regimen B: ABT-450/r/ABT-267 Receives: Drug: ABT-450/r/ABT-267 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute bioavailability
dose normalized AUC(0-inf) for oral dose/dose normalized AUC(0-inf) for IV dose
Measured: Day 1 until 72 hours after single dose of ABT-450/r/ABT-267
Secondary outcomes (4)
Safety Labs
Chemistry, Haematology, Urinalysis
Measured: Day -1 until 72 hours after single dose of ABT-450/r/ABT-267
Electrocardiograms (ECGs)
The measure of any change in 12 lead electrocardiogram from Day-1
Measured: Day-1 until 24 hours after single dose of ABT-450/r/ABT-267
Number of participants with adverse events
Measured: Screening until 7 days after single dose of ABT-450/r/ABT-267
Physical Exam
To examine any change from Day-1 in the subject's physical presentation (body temperature, blood pressure, pulse)
Measured: Day-1 until 72 hours after single dose ABT-450/r/ABT-267
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Absolute BioavailabilityStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Armen Asatryan, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052362
- Sponsor's protocol ID
- M14-229
- Other IDs
- 2013-003685-14
- Status last verified
- Feb 2014
- First submitted
- 30 Jan 2014
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Single Centre Study Designed to Determine the Absolute Bioavailability of ABT-450 (150 mg) and ABT-267 (25 mg) When Administered as an Oral Co-Formulated Product With Ritonavir (100 mg), ABT 450/r/ABT 267, to Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02052362
- Acronym / sponsor ID
- M14-229
- Conditions
- Absolute Bioavailability
- Keywords
- absolute bioavailability, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 3 Feb 2014 (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.
A study to investigate the fraction of ABT-267 and ABT-450 absorbed by the body when given in combination with each other and Ritonavir(r).
Detailed description
Absolute bioavailability of ABT-267 and ABT-450 in the body when given together
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Regimen A | Experimental | Drug: ABT-450/r/ABT-2678 Subjects in Group I - Regimen A: ABT-450/r/ABT-267 |
| Group 2 - Regimen B | Experimental | Drug: ABT-450/r/ABT-2678 Subjects in Group II - Regimen B: ABT-450/r/ABT-267 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy males or non-pregnant, non-lactating healthy females
- Body mass index of 18.0 to 30.0 kg/m2
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Must agree to use an adequate method of contraception
Key exclusion criteria (6 listed)
- Participation in a clinical research study within the previous 3 months or in an absorption, distribution, metabolism, and excretion (ADME) study within the previous 12 months
- History of any drug or alcohol abuse in the past 2 years or current smokers and those who have smoked within the last 12 months or a positive cotinine urine test at screening and admission
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- Donation or loss of greater than 550 mL of blood (including plasmapheresis) or receipt of a transfusion of any blood product within the previous 8 weeks
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-450/r/ABT-267ABT-450, ABT-267 and ritonavir | Drug | Group 1 - Regimen A, Group 2 - Regimen B |
Primary outcome
Absolute bioavailability
Time frame: Day 1 until 72 hours after single dose of ABT-450/r/ABT-267
dose normalized AUC(0-inf) for oral dose/dose normalized AUC(0-inf) for IV dose
4 secondary outcomes
Safety Labs
Time frame: Day -1 until 72 hours after single dose of ABT-450/r/ABT-267
Electrocardiograms (ECGs)
Time frame: Day-1 until 24 hours after single dose of ABT-450/r/ABT-267
Number of participants with adverse events
Time frame: Screening until 7 days after single dose of ABT-450/r/ABT-267
Physical Exam
Time frame: Day-1 until 72 hours after single dose ABT-450/r/ABT-267
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 19 Feb 2014.
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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.
Armen Asatryan, MD study director
AbbVie
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/r/ABT-267 in people with Absolute Bioavailability, run by AbbVie at 1 site in United Kingdom.
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 6 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 19 Feb 2014. 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 Kingdom. 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?
Absolute bioavailability (time frame: Day 1 until 72 hours after single dose of ABT-450/r/ABT-267). 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 19 Feb 2014.