Trials Sponsors Conditions Drugs Pricing

Conditions

Rheumatoid Arthritis

Keywords

moderate Rheumatoid Arthritissevere Rheumatoid ArthritissubcutaneousOlokizumabdrug interactionCYP450

Outcome Measures

Primary Outcomes (3)

Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC(0-inf)) for Caffeine, Omeprazole and Midazolam
Area under the AUC from time zero extrapolated to infinity, calculated by linear up/log down trapezoidal summation. In case of anomalous predose concentration of greater than 5% of Cmax was indicated, the PK parameters for the affected analyte and given subject were excluded from the analyses. Since caffeine is contained in the plethora of foods and beverages, most subjects had predose caffeine concentrations on Day 1 and Day 22 that exceeded 5% of their Maximum plasma concentration (Cmax). Caffeine PK parameter calculations and analyses were performed using concentrations adjusted by subtracting the contribution of the predose caffeine levels at each postdose timepoint using the following equation: Concentration (adjusted) = Concentration (observed) - \[C predose \* exp(-k\*t)\], with 'k' representing the patient-specific elimination rate constant (λz) determined using observed caffeine concentration data on Day 1 and Day 22 and 't' representing the actual time postdose.
Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 7, 12, 24 (Day 2), 30 (Day 2, only caffeine) hours post-dose; Day 22: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 7, 12, 24 (Day 23), 30 (Day 23, only caffeine) hours post-dose
AUC From Time Zero to the Time "t" (AUC(0-last)) for S-warfarin
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration, calculated by linear up/log down trapezoidal summation for S-warfarin (10 mg warfarin contains 5 mg S-warfarin)
Day 1: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 7, 12, 24(Day 2), 48(Day 3), 72 (Day 4), 120 (Day 6), 168 (Day 8) hours post-dose; Day 22: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 7, 12, 24(Day 23), 48(Day 24), 72 (Day 25), 120 (Day 27), 168 (Day 29) hours post-dose

Secondary Outcomes (10)

Plasma AUC(0-last) for Cocktail Parent Compounds (for Caffeine, Omeprazole and Midazolam)
Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 7, 12, 24 (Day 2), 30 (Day 2, only caffeine) hours post-dose; Day 22: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 7, 12, 24 (Day 23), 30 (Day 23, only caffeine) hours post-dose
Plasma AUC From Time Zero to Infinity (AUC(0-inf)) for Cocktail Parent Compounds (for S-warfarin)
Day 1: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 7, 12, 24, 48, 72, 120, 168 hours post-dose; Day 22: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 7, 12, 24, 48, 72, 120, 168 hours post-dose
Time to Maximum Plasma Concentration (Tmax) for Cocktail Parent Compounds
Day 1: pre-dose, 0.5 - 24, 30 (only caffeine), 48 (only S-warfarin), 72 (only S-warfarin), 120 (only S-warfarin), 168 (only S-warfarin) hours post-dose; Day 22: pre-dose, 0.5 - 24, 30 (only caffeine), 48 - 168 (only S-warfarin) hours post-dose
Terminal Half-life (t1/2) for Cocktail Parent Compounds
Day 1: pre-dose, 0.5 - 24, 30 (only caffeine), 48 - 168 (only S-warfarin) hours post-dose; Day 22: pre-dose, 0.5 - 24, 30 (only caffeine), 48 - 168 (only S-warfarin) hours post-dose
Elimination Rate Constant (λz) for Cocktail Parent Compounds

Study Arms (1)

Olokizumab 128 mg +Cocktail drugs

EXPERIMENTAL

All subjects have received the following treatment: Cocktail drugs (Omeprazole + Caffeine + Warfarin (+ vitamin K solution) + Midazolam) orally administered with 240 mL of water on Day 1, single subcutaneous injection of Olokizumab 128 mg administered on Day 8 and second dose of Cocktail drugs (Omeprazole + Caffeine + Warfarin (+ vitamin K solution) + Midazolam) orally administered on Day 22

Drug: OlokizumabDrug: OmeprazoleDrug: CaffeineDrug: Warfarin+ Vitamin KDrug: Midazolam

Interventions

OlokizumabDrug

Sterile solution for subcutaneous (SC) injection, 128 mg (0.8 mL injection)

Olokizumab 128 mg +Cocktail drugs

OmeprazoleDrug

Tablets, 20 mg, oral

Olokizumab 128 mg +Cocktail drugs

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects willing and able to give voluntary informed consent and sign an Informed Consent Form (ICF)
Male subjects and their female partners and female subjects of childbearing potential must agree to adhere to the contraceptive requirements for the study

Sponsors & Collaborators

IQVIA Pvt. Ltd
Industrycollaborator
Thermo Fisher Scientific FS
Othercollaborator
R-Pharm International, LLC

Study Sites (2)

Comac Medical Ltd

Sofia, 1618, Bulgaria

ICS ARENSIA Exploratory Medicine SRL, a daughter company of ARENSIA Exploratory Medicine GmbH,Republican Clinical Hospital

Chisinau, MD2025, Moldova

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

olokizumabOmeprazoleCaffeineMidazolam

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Results Point of Contact

Title: Marina Beloukhova, Scientific advisor
Organization: R-Pharm

Study Officials

Mikhail Samsonov
Chief Medical Officer, R-Pharm
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

17 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 27, 2020

First Posted

January 29, 2020

Study Start

November 16, 2021

Actual (reported)

You may not qualify if:

Diagnosis of any other inflammatory arthritis or systemic inflammatory disease (e.g., gout, psoriatic or reactive arthritis, Crohn's disease, Lyme disease, juvenile idiopathic arthritis, or systemic lupus erythematosus). Osteoarthritis is classified as a degenerative disease rather than an inflammatory disease.
Subjects with Steinbrocker Class III or IV functional capacity (incapacitated, largely, or wholly bed ridden, or confined to a wheelchair, with little, or no self-care).
Prior exposure to any licensed or investigational compound directly or indirectly targeting IL-6 or IL-6R within 12 months of Day 1.
Treatment with DMARDs other than MTX, hydroxychloroquine, or sulfasalazine. Treatment with the following DMARDs are not allowed within the specified time period prior to Day 1:
weeks for azathioprine, cyclosporine, chloroquine, gold, penicillamine, minocycline, or doxycycline.
weeks for leflunomide unless the subject has completed the following elimination procedure at least 4 weeks prior to Day 1: Cholestyramine at a dosage of 8 grams 3 times daily for at least 24 hours or activated charcoal at a dosage of 50 grams 4 times a day for at least 24 hours.
weeks for cyclophosphamide.
Treatment with any cell-depleting therapies including anti-cluster of differentiation (CD)20 or investigational agents (eg, CAMPATH®, anti-CD4, anti-CD5, anti-CD3, and anti-CD19) with the exception of rituximab. Treatment with rituximab is not allowed within 6 months of Day 1.
Treatment with Tumor necrosis factor alpha inhibitor (TNFi) (including investigational proposed or licensed biosimilars) or any other biologic therapy for the treatment of RA within 12 weeks of Day 1.
Use of parenteral or intra-articular glucocorticoids within 4 weeks prior to Day 1.
Use of oral glucocorticoids greater than 10 mg/day prednisone (or equivalent) or change in dosage within 4 weeks prior to Day 1.
Use of indomethacin and ketorolac; other nonsteroidal anti-inflammatory drugs (NSAIDs) (with the exception of aspirin, see below) must be taken at a stable dose and route of administration for at least 2 weeks prior to Day 1.
Female subjects of nonchildbearing potential taking hormone replacement therapy within 4 weeks prior to Day 1.
Vaccination with live vaccines in the 6 weeks prior to Day 1 or planned vaccination with live vaccines during the study.
Participation in any other investigational drug study within 30 days or 5 times the t1/2 of the investigational drug, whichever is longer, prior to Day 1.
+57 more criteria

Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19 and CYP3A4

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (10)

Study Arms (1)

Olokizumab 128 mg +Cocktail drugs

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Named ingredients in these interventions

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (10)

Study Arms (1)

Olokizumab 128 mg +Cocktail drugs

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Named ingredients in these interventions

You may not qualify if:

Source record

Documents

Locations