Moderate to Severe Plaque PsoriasisPhase 1NCT01260844
Open Label, Single Dose, Non-randomized Study to Assess the Drug to Drug Interaction of Briakinumab on CYP Substrates.
A Phase 1 study testing briakinumab in people with Moderate to Severe Plaque Psoriasis, run by Abbott.
Trial summary
Phase 1, drug-drug interaction study to evaluate the effects of Briakinumab on hte pharmacokinetics of single doses of CYP substrate in subjects with moderate to severe psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis
- What is being tested?
- briakinumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to not given
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Male or female and age is between 18 and 55 years, inclusive.
- Clinical diagnosis of plaque psoriasis for at least 6 months as determined by subject's interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator.
- Moderate to severe plaque psoriasis defined by ≥ 10% Body Surface Area (BSA) involvement at the Screening visit and Day -2 visit.
- PGA of at least moderate (defined as a PGA of ≥3) disease at the Screening visit and Day -2 visit.
- Subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray, and 12-lead electrocardiogram (ECG) performed at Screening.
- Females must have negative results on all pregnancy tests during the study.
- Body Mass Index (BMI) is between 18 to 29, inclusive.
Who cannot join
- History of either Type 1 or 2 diabetes
- History of significant sensitivity to any drug
- History of drug or alcohol abuse within 6 months prior to screening
- Receipt of any investigational product within 1 month prior to day -2 , or current participation in any clinical study receiving any study drug or device
- Use of known CYP inhibitors (e.g., ketoconazole, clotrimazole) or inducers (e.g., dexamethasone, phenytoin, rifampin, carbamazepine) within 1 month prior to Day -2
- Use of known CYP substrates, (including hormonal contraception), within 1 month prior to Study Day-2. See Appendix E for List of Cytochrome P450 (CYP) Medications for the Treatment of Hypertension and Dyslipidemia
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- Receipt of any vaccine within 3 months prior to study drug administration
- Subject has received vaccination with Bacille Calmette-Guérin (BCG)
- Previous exposure to systemic anti-IL-12/23 therapy, including briakinumab (ABT-874) or ustekinumab.
- Cannot discontinue systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis, during the study:
- Non-biologic systemic (investigational or marketed) therapies must be discontinued at least 1 month prior to the Day-2
- Biologic (investigational or marketed) therapies must be discontinued at least 12 weeks prior to Day-2
- Subjects that must use topical therapies for the treatment of psoriasis such as corticosteroids, vitamin D analogs, or retinoids during the study. Subjects are allowed to use:
- Shampoos that contain no corticosteroid;
- Bland (without beta or alpha hydroxy acids) emollients;
- Low potency (Class VI or Class VII) topical corticosteroids on the palms, soles, face, inframammary area, and groin only. See Appendix F for a Listing of Examples of Class VI and VII Topical Corticosteroids
- Cannot avoid PUVA phototherapy during the study.
- Subject is taking or requires oral, injectable or inhaled corticosteroids during the study.
- Use of herbal or dietary supplements, such as St. John's Wort, within 1 month prior to Day -2 or 10 half lives whichever is longer.
- Use of caffeine and/or theobromine (coffee, chocolate, tea, cola drinks, mountain dew etc.) within three days prior to Day-2 and Day 12.
- Consumption of orange, grapefruit or orange or grapefruit products (juices), broccoli, brussels sprouts, or charcoal grilled meats within three days prior to Day-2 and Day 12
- Consumption of alcohol within the 48 hours prior to Day-2 and Day 12.
- Use of tobacco or nicotine-containing products within the 6-month period preceding Day-2.
- Positive screen for drugs of abuse, alcohol or cotinine
- Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study or in the 60 days after receiving the single dose of study drug
- Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or HIV antibodies (HIV Ab). Negative HIV status will be confirmed at Screening, and the results will be maintained and communicated to the subjects confidentially by the study site.
- History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption
- Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks Day-2.
- Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication exacerbated psoriasis, or new onset guttate psoriasis.
- Poorly controlled medical condition, such as documented history of recurrent infections, unstable ischemic heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition, or an unstable psychiatric condition which, in the opinion of the investigator and/or Abbott's Medical Monitor, would put the subject at risk by participation in the study
- Subject has infection or risk factors for severe infections, for example:
- Active tuberculous disease;
- Evidence of latent tuberculosis (TB) infection demonstrated by a positive result of their Purified Protein Derivative (PPD) skin test
- Subject is taking TB prophylaxis medication
- Any other significant infection requiring hospitalization or intravenous (IV) antibiotics in the month prior to Day -2;
- Infection requiring treatment with antibiotics in the month prior to Day -2
- History of atherosclerotic cardiovascular disease as manifested by any of the following:
- History of malignancies other than successfully treated basal cell carcinoma, non-metastatic cutaneous squamous cell carcinoma or cervical carcinoma in situ
- Exacerbation of asthma requiring hospitalization in the 10 years prior to screening.
About this study
Official title: An Open-Label Study to Evaluate the Effect of a Single Dose of Briakinumab on the Pharmacokinetics of Single Doses of Caffeine, Tolbutamide, Omeprazole, Metroprolol, and Midazolam in Subjects With Moderate to Severe Psoriasis
Phase 1, drug-drug interaction study to evaluate the effects of Briakinumab on hte pharmacokinetics of single doses of CYP substrate in subjects with moderate to severe psoriasis.
Read the detailed description
The study does involve 3 days confinement at the beginning of the trial and 4 days at the end of the trial. The trial duration is 17 days with 6 visits not including the confinement periods. The trial is being conducted in moderate to severe plaque psoriasis subjects. Serial blood samples will be taken after each doses of the CYP substrates are administered and blood samples will be collected for briakinumab PK and briakinumab ADA.
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- briakinumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
briakinumabDrug
Also called ABT-874 Briakinumab
single dose briakinumab and 2 doses of CYP substrates
| Study group | Role | What they receive |
|---|---|---|
| single dose of briakinumab | Experimental | single dose briakinumab cocktail of CYP substrates Receives: Drug: briakinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the drug-drug interaction potential of briakinumab (ABT-874) with cytochrome CYP 1A2. CYP2C9, CYP2C19, CYP2D6 and CYP3A4 in moderate to severe plaque psoriasis subjects
CYP Substrate cocktail administed at Day -1 and day 14 and Briakinumab at Day 1
Measured: 17 days
Secondary outcomes (1)
No secondary outcomes are reported for this study
No secondary outcomes are reported for this study
Measured: No secondary outcomes are reported for this study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startApr 2011
Why it stopped: Study stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Plaque PsoriasisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David A Williams, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260844
- Sponsor's protocol ID
- M12-160
- Status last verified
- May 2011
- First submitted
- 14 Dec 2010
- Last updated
- 21 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Effect of a Single Dose of Briakinumab on the Pharmacokinetics of Single Doses of Caffeine, Tolbutamide, Omeprazole, Metroprolol, and Midazolam in Subjects With Moderate to Severe Psoriasis
- ClinicalTrials.gov ID
- NCT01260844
- Acronym / sponsor ID
- M12-160
- Conditions
- Moderate to Severe Plaque Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- First posted
- 15 Dec 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.
Phase 1, drug-drug interaction study to evaluate the effects of Briakinumab on hte pharmacokinetics of single doses of CYP substrate in subjects with moderate to severe psoriasis.
Detailed description
The study does involve 3 days confinement at the beginning of the trial and 4 days at the end of the trial. The trial duration is 17 days with 6 visits not including the confinement periods. The trial is being conducted in moderate to severe plaque psoriasis subjects. Serial blood samples will be taken after each doses of the CYP substrates are administered and blood samples will be collected for briakinumab PK and briakinumab ADA.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single dose of briakinumab | Experimental | Drug: briakinumabsingle dose briakinumab cocktail of CYP substrates |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female and age is between 18 and 55 years, inclusive.
- Clinical diagnosis of plaque psoriasis for at least 6 months as determined by subject's interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator.
- Moderate to severe plaque psoriasis defined by ≥ 10% Body Surface Area (BSA) involvement at the Screening visit and Day -2 visit.
- PGA of at least moderate (defined as a PGA of ≥3) disease at the Screening visit and Day -2 visit.
- Subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray, and 12-lead electrocardiogram (ECG) performed at Screening.
Key exclusion criteria (39 listed)
- History of either Type 1 or 2 diabetes
- History of significant sensitivity to any drug
- History of drug or alcohol abuse within 6 months prior to screening
- Receipt of any investigational product within 1 month prior to day -2 , or current participation in any clinical study receiving any study drug or device
- Use of known CYP inhibitors (e.g., ketoconazole, clotrimazole) or inducers (e.g., dexamethasone, phenytoin, rifampin, carbamazepine) within 1 month prior to Day -2
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 |
|---|---|---|
| briakinumabAlso: ABT-874 Briakinumabsingle dose briakinumab and 2 doses of CYP substrates | Drug | single dose of briakinumab |
Primary outcome
Assessment of the drug-drug interaction potential of briakinumab (ABT-874) with cytochrome CYP 1A2. CYP2C9, CYP2C19, CYP2D6 and CYP3A4 in moderate to severe plaque psoriasis subjects
Time frame: 17 days
CYP Substrate cocktail administed at Day -1 and day 14 and Briakinumab at Day 1
1 secondary outcome
No secondary outcomes are reported for this study
Time frame: No secondary outcomes are reported for this study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2011.
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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.
David A Williams, MD study director
Abbott
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing briakinumab in people with Moderate to Severe Plaque Psoriasis, run by Abbott.
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 7 inclusion and 39 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: withdrawn, as of the sponsor's last update on 21 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 the drug-drug interaction potential of briakinumab (ABT-874) with cytochrome CYP 1A2. CYP2C9, CYP2C19, CYP2D6 and CYP3A4 in moderate to severe plaque psoriasis subjects (time frame: 17 days). 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 Oct 2011.