Open Label, Single Dose, Non-randomized Study to Assess the Drug to Drug Interaction of Briakinumab on CYP Substrates.

NCT01260844 | Withdrawn Phase 1

• 1 other identifier: M12-160
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Moderate to Severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

  17 days

Secondary Outcomes (1)

• No secondary outcomes are reported for this study

  No secondary outcomes are reported for this study

Study Arms (1)

single dose of briakinumab

EXPERIMENTAL

single dose briakinumab cocktail of CYP substrates

Drug: briakinumab

Interventions

briakinumab DRUG

single dose briakinumab and 2 doses of CYP substrates

Also known as: ABT-874 Briakinumab

single dose of briakinumab

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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;

Sponsors & Collaborators

• Abbott: lead

MeSH Terms

Interventions

briakinumab

Study Officials

• David A Williams, MD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 15, 2010
• Study Start: April 1, 2011
• Last Updated: October 21, 2011

Record last verified: 2011-05