Pharmacokinetic Study to Evaluate the Effect of a Single Dose of Guselkumab (CNTO 1959) on CYP 450 Enzyme Activities After Subcutaneous Administration in Participants With Psoriasis
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 9/21/2017 |
Start Date: | June 18, 2015 |
End Date: | August 31, 2016 |
A Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Guselkumab (CNTO 1959) on Cytochrome P450 Enzyme Activities Following a Single Subcutaneous Administration in Subjects With Moderate to Severe Plaque-type Psoriasis
The purpose of this study is to evaluate the potential effects of a single dose of 200
milligram (mg) guselkumab on the plasma concentrations of a cocktail of representative probe
substrates of Cytochrome P450 isozymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) in
participants with moderate to severe psoriasis.
milligram (mg) guselkumab on the plasma concentrations of a cocktail of representative probe
substrates of Cytochrome P450 isozymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) in
participants with moderate to severe psoriasis.
This is an open-label, multi-center study. The total duration of study will be approximately
17 weeks per participant, including Screening phase (up to 4 weeks prior to first probe
cocktail administration). Participants will have 4 in-patient periods on Day 1, 8, 15 and 36
(3 periods consisting of 3 days and 2 nights each and 1 consisting of 2 days and 1 night)
followed by follow up period (up to Day 92). All Participants will receive a single 200 mg
subcutaneous (SC) injection (2*100 mg) of guselkumab on Day 8 and probe cocktail on Days 1,
15 and 36. Blood samples will be collected for the evaluation of pharmacokinetics and
immunogenicity at pre-dose and post-dose of study treatment. Participants' safety will be
monitored throughout the study.
17 weeks per participant, including Screening phase (up to 4 weeks prior to first probe
cocktail administration). Participants will have 4 in-patient periods on Day 1, 8, 15 and 36
(3 periods consisting of 3 days and 2 nights each and 1 consisting of 2 days and 1 night)
followed by follow up period (up to Day 92). All Participants will receive a single 200 mg
subcutaneous (SC) injection (2*100 mg) of guselkumab on Day 8 and probe cocktail on Days 1,
15 and 36. Blood samples will be collected for the evaluation of pharmacokinetics and
immunogenicity at pre-dose and post-dose of study treatment. Participants' safety will be
monitored throughout the study.
Inclusion Criteria:
- Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis (PsA)
for at least 6 months before Day 1
- Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at
Screening
- Have an Investigator's Global Assessment (IGA) >= 3 at Screening
- Have an involved body surface area (BSA) >= 10 percent (%) at Screening
- Be a candidate for phototherapy or systemic treatment for psoriasis
Exclusion Criteria:
- Has a history of or current signs or symptoms of severe, progressive, or uncontrolled
renal, hepatic, cardiac (including unstable cardiovascular disease, defined as a
recent clinical deterioration (example, unstable angina, rapid atrial fibrillation) in
the last 3 months or a cardiac hospitalization within the last 3 months), vascular,
pulmonary, gastrointestinal, endocrine, neurologic, hematologic, bleeding disorder,
rheumatologic, psychiatric, or metabolic disturbances
- Have a pulse oximetry value less than (<) 94 % at Screening
- Genetically determined poor metabolizers of CYP2C9, CYP2C19, and CYP2D6 substrates
- Is currently undergoing or has previously undergone allergy immunotherapy for a
history of anaphylactic reactions
- Has a transplanted organ (with exception of a corneal transplant greater than (>) 3
months before Day 1)
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