A Study to Investigate Safety, Tolerability, and PK of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis
A Phase 1, Randomized, Placebo-controlled, Double-blind, Multiple Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis
1 other identifier
interventional
32
1 country
8
Brief Summary
The study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of multiple orally administered TCK-276 in both males and females with Rheumatoid Arthritis (RA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 rheumatoid-arthritis
Started Aug 2022
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2022
CompletedFirst Posted
Study publicly available on registry
June 29, 2022
CompletedStudy Start
First participant enrolled
August 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2023
CompletedResults Posted
Study results publicly available
October 15, 2024
CompletedOctober 15, 2024
October 1, 2024
11 months
June 23, 2022
June 3, 2024
October 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number ot Participants With Treatment Emergent Adverse Events
To evaluate the safety and tolerability of multiple oral doses of TCK-276 or placebo in patients with rheumatoid arthritis (RA)
42 days (duration of study)
Secondary Outcomes (18)
Cmax: Plasma Concentrations of TCK-276 and TEI-W00595 (Metabolite)
Day 1 and Day 7
Tmax: Time of Maximum Plasma Concentration Determined Directly From the Concentration-time Profile
Day 1 and Day 7
t½: Terminal Elimination Half-life
Day 1 and Day 7
AUCtau: Area Under the Plasma Concentration-time Curve Over a Dosing Interval, Tau = 24 Hours
Day 1 and Day 7
AUC0-inf: Area Under the Plasma Concentration Time Curve From Pre-dose (Time 0) Extrapolated to Infinite Time
Day 1 and Day 7
- +13 more secondary outcomes
Study Arms (4)
Cohort 1
EXPERIMENTALThe patient will receive Dose A of TCK-276 or matching placebo orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
Cohort 2
EXPERIMENTALThe patient will receive Dose B of TCK-276 or matching placebo orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
Cohort 3
EXPERIMENTALThe patient will receive Dose C of TCK-276 or matching placebo orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
Cohort 4
EXPERIMENTALThe patient will receive Dose D of TCK-276 or matching placebo orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
Interventions
Patients will receive an oral dose of TCK-276 QD under fed conditions from Day 1 to Day 7.
Patients will receive an oral dose of TCK-276 matching placebo QD under fed conditions from Day 1 to Day 7.
Eligibility Criteria
You may qualify if:
- Diagnosis of RA and meeting the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for RA.
- Patients between the ages of 18 and 64 years, inclusive, at the Screening Visit.
- Female patient must be not pregnant, not breast feeding and one of the following conditions need to apply:
- Of non-childbearing potential based on documented surgical treatment or post-menopausal, meaning patient had spontaneous amenorrhea for at least 12 months without alternate medical cause prior to Screening Visit and follicle stimulating hormone (FSH) \> 40 U/mL at the Screening Visit.
- Of childbearing potential and using a highly effective method of contraception and agrees to remain on a highly effective method from the time of signing the informed consent form (ICF) until 21 days after the last dose.
- Male patient must agree to stay abstinent or must use together with his female partner(s) a form of highly effective contraceptive (failure rate of \< 1% per year) from the time of signing the ICF until up to 3 months after the last dose of the study drug.
- Nonsmokers (or other nicotine use) as determined by history and by negative urine cotinine concentration at the Screening Visit and at Admission.
- Body mass index (BMI) between 18.5 and 32.0 kg/m2, inclusive, at the Screening Visit.
- Patient is required to have completed a COVID-19 vaccine regimen within no more than 5 months prior to screening to be eligible for the study.
- Permitted concomitant medications for any reason, must be on a stable dose.
- Permitted medications include: anti-malarials; nonsteroidal anti-inflammatory drugs including selective cyclooxygenase-2 inhibitors at approved dosage, and low dose oral corticosteroids; methotrexate concomitantly with folic acid or folinic acid.
You may not qualify if:
- Female patients who are breastfeeding or have a positive urine pregnancy test.
- Patients who are unable to eat the prescribed meals during the stay at the site; vegetarian or vegan.
- Patient has a history of significant drug allergy.
- Patient has used a study drug, any prohibited medication(s), over-the-counter (OTC) medications, vitamins, dietary and herbal supplements.
- Patient has a history of active suicidal ideation, or any psychiatric disorders that will affect the patient's ability to participate in the study.
- Patient has a current or recent history of uncontrolled, clinically significant infectious, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- Patient with any of the laboratory abnormalities as per reference.
- Patient has a history of alcohol and/or drug abuse within 24 weeks.
- Patient has positive results for drug testing and breath alcohol test.
- Regular consumption of alcohol within 6 months prior to the Screening Visit.
- Patient has positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis B core (HBc) antibodies, hepatitis C virus (HCV) antibody, and/or human immunodeficiency virus (HIV) antibody at Screening Visit.
- Patient has QT interval corrected for heart rate (QTc) using Fridericia's correction (QTcF) \> 450 ms for males or QTcF \> 470 ms for females either at the Screening Visit or Admission, based on safety 12-lead electrocardiogram (ECG). Patient has Screening or Admission ECG with second- or third-degree atrioventricular block, bundle branch block, arrhythmia (but not sinus arrhythmia or supraventricular premature beats), or illegible QT interval.
- Patient has history or evidence of cardiopathy, acute coronary syndrome, hypertrophic cardiomyopathy, myocarditis or QT prolongation syndrome.
- Patient is unwilling to abstain from drinks and foods containing alcohol, grapefruit, or caffeine
- Patient has donated blood or experienced acute blood loss (including plasmapheresis) of greater than 500 mL within 90 days prior to the first dose of study drug.
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Teijin America, Inc.lead
- Parexelcollaborator
Study Sites (8)
Orange County Research Center
Tustin, California, 92780, United States
St. Jude Clinical Research, LLC
Doral, Florida, 33172, United States
SouthCoast Research Center, Inc
Miami, Florida, 33136, United States
Allied Biomedical Research Institute
Miami, Florida, 33155, United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014, United States
Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016, United States
Clinical Site Partners, LLC dba CSP Orlando
Winter Park, Florida, 32789, United States
SMS Clinical Research, LLC
Mesquite, Texas, 75149, United States
Related Publications (1)
Tasaki D, Tsuruda K, Sun S, Tsumura Y, Asano S, Suzuki Y, Tsujimoto S, Miura D, Sato H. A double-blind, placebo-controlled, randomized multiple dose phase 1b trial of a CDK4/6 inhibitor, TCK-276, in patients with active rheumatoid arthritis. Rheumatology (Oxford). 2025 Mar 1;64(3):1036-1044. doi: 10.1093/rheumatology/keae357.
PMID: 39002122DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- President
- Organization
- Teijin America, Inc.
Study Officials
- STUDY DIRECTOR
Tatyana Zubkovskaya
Medical Director
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2022
First Posted
June 29, 2022
Study Start
August 10, 2022
Primary Completion
July 20, 2023
Study Completion
July 27, 2023
Last Updated
October 15, 2024
Results First Posted
October 15, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Beginning 3 months and ending 5 years following article publication.
- Access Criteria
- Researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.
Individual participant data will be shared that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Proposals should be directed to clinical-trials-contact@teijinpo.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included).