Clinical trial NCT01866007: A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants
Official title: Phase 1, Open-label, Randomized, Parallel Study to Assess the Pharmacokinetic Comparability of 2 Formulations and to Evaluate Pharmacokinetic Comparability of Guselkumab (CNTO1959) Delivered by 2 Different Devices in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Guselkumab
CNTO1959
Pharmacokinetics
UltraSafe Passive Delivery System (PFS-U)
Prefilled syringe facilitated injection device (PFS FID)
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2013-05-31
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetic (what the body does to the medication) comparability of guselkumab in lyophilized and liquid formulations. Also to evaluate pharmacokinetic comparability of liquid formulation of guselkumab when delivered as prefilled syringe with UltraSafe Passive Delivery System \[PFS-U\] or with a prefilled syringe facilitated injection device \[PFS FID\]) following a single subcutaneous (SC) administration of 100 mg guselkumab in healthy participants.

Detailed description: This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), parallel study (each group of participants will be treated at the same time) of guselkumab in healthy participants. Approximately 140 participants will be randomly assigned in the ratio 2:2:2:1 in to 4 treatment groups: Group 1 (SC injection of lyophilized formulation), Group 2 (subcutaneous \[SC\] injection of liquid formulation with PFS-U), Group 3 (SC injection of liquid formulation with PFS-FID), and Group 4 (IV infusion of liquid formulation). The study consists of 3 phases: screening (up to 4 weeks), open-label treatment and inpatient follow up (1 week) and outpatient follow up (11 weeks). Safety evaluations will include assessment of adverse events, vital signs, physical examination, electrocardiograms, injection-site reactions, and clinical laboratory tests. The total duration of the study for each participant will be approximately 16 weeks.

Eligibility criteria: Inclusion Criteria:

* Healthy participant with no clinically significant abnormalities
* Have a weight in the range of 60 kg to 90 kg for male participants; have a weight in the range of 50 kg to 80 kg for female participants
* Have a body mass index (BMI) of 18.5 kg/m2 to 29.0 kg/m2
* Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

* Participant has a history of any clinically significant medical illness including liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, ophthalmological disorders, neoplastic disease, urinary tract diseases, or dermatological disease
* Currently have any known malignancy or have a history of malignancy
* Participant has a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins to monoclonal antibodies or antibody fragments
* Have had a Bacillus Calmette-Guérin (BCG) vaccination within 12 months of screening

Primary outcomes:
measure: Maximum observed serum concentration (Cmax) of guselkumab
timeFrame: Day 1 through Week 12
measure: Area under the curve (AUC) from time 0 to 70 days of guselkumab
timeFrame: Day 1 through Week 12
Secondary outcomes:
measure: Absolute bioavailability of guselkumab
timeFrame: Day 1 through Week 12
measure: Immunogenicity of guselkumab
timeFrame: Day 1 through Week 12
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Tempe
country: United States
state: Arizona
city: Lincoln
country: United States
state: Nebraska
city: Neptune
country: United States
state: New Jersey
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: