Rheumatoid ArthritisPhase 1NCT05437419
A Study to Investigate Safety, Tolerability, and PK of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis
A Phase 1 study testing TCK-276 in people with Rheumatoid Arthritis, run by Teijin America, Inc. at 8 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- TCK-276
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 8 sitesUnited States
- Study dates
- 10 Aug 2022to 27 Jul 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 35Show fewer
- 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.
- Patients with a known immunodeficiency disorder. Have a history of a major organ transplant or hematopoietic stem cell/marrow transplant.
- Patients with infections requiring treatment or hospitalization within 14 days prior to the Screening Visit, parenteral antimicrobial therapy within 60 days prior to the Screening Visit, infected joint prosthesis; history of herpes zoster, active herpes simplex, or herpes simplex on suppressive therapy.
- Patient has a chronic hepatic disease or hepatic impairment.
- Patient has a history of Mycobacterium tuberculosis or positive interferon gamma release assay for tuberculosis (IGRA-TB) or abnormal chest X-ray (for positive IGRA-TB patients).
- Patient has a history of any lymphoproliferative disorder.
- Patient has a history of COVID-19 unless fully recovered with no sequelae for 14 days.
- Patient who had a severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated).
- Patient who has recent exposure to someone who has COVID-19 symptoms or positive test result.
- Patient who has a positive reverse transcription polymerase chain reaction (RT-PCR) test for Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2).
- Patient who has clinical signs and symptoms consistent with SARS-CoV-2 infection.
- Patients may not receive any live/attenuated vaccine from 30 days prior to the Screening Visit until Day 14 Follow-up Visit.
- COVID-19 vaccine should not be given 1 week prior to the Screening Visit.
- Patients with malignancy or history of malignancy except adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. Previous treatment with total lymphoid irradiation.
- History of recurrent inflammatory joint disease other than RA or history of any other autoimmune rheumatic diseases other than Sjogren's syndrome.
- Major surgery within 30 days prior to the Screening Visit or patients with planned surgery.
- Patients who have an abnormal chest X-ray for interstitial lung disease (ILD) and/or patients with history of ILD.
- History of fainting or family history of sudden death.
- Patient has any disorder that would interfere with the absorption, distribution, metabolism or excretion of study drug.
- Patient has a history of deep vein thrombosis and/or pulmonary embolism.
- Patient has poor venous access.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
St. Jude Clinical Research, LLC
Doral, Florida, 33172
SMS Clinical Research, LLC
Mesquite, Texas, 75149
SouthCoast Research Center, Inc
Miami, Florida, 33136
Allied Biomedical Research Institute
Miami, Florida, 33155
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014
Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016
Orange County Research Center
Tustin, California, 92780
Clinical Site Partners, LLC dba CSP Orlando
Winter Park, Florida, 32789
About this study
Official title: 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
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).
Read the detailed description
This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled, multiple ascending dose (MAD) study.
The study will consist of a Screening Visit (Days -1 to Day 10), Treatment duration (up to 11 days) and a Follow-up/end of treatment (EOT) visit.
This MAD study will consist of 4 cohorts of 8 patients (6 active treatment and 2 matching placebo, or a 3:1 ratio), each receiving an oral dose of TCK-276 or matching placebo for 7 days (once daily (QD) under fed condition). The first cohort will be divided into 2 subgroups to implement the sentinel dosing approach.
The study duration is approximately 42 days.
- Conditions
- Rheumatoid Arthritis
- Being tested
- TCK-276, TCK-276 Placebo
- Keywords
- Multiple Ascending Dose, autoimmune disease, Disease modifying antirheumatic drugs (DMARD)
- Medical subject headings
- Arthritis, Rheumatoid, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCK-276Drug
Also called Cyclin Dependent Kinase 4/6 (CDK 4/6) Inhibitor, TEI-T01276
Patients will receive an oral dose of TCK-276 QD under fed conditions from Day 1 to Day 7.
TCK-276 PlaceboDrug
Also called Placebo
Patients will receive an oral dose of TCK-276 matching placebo QD under fed conditions from Day 1 to Day 7.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | The patient will receive Dose A of TCK-276 or matching placebo orally from Day 1 to Day 7 (once daily (QD) under fed conditions). Receives: Drug: TCK-276; Drug: TCK-276 Placebo |
| Cohort 2 | Experimental | The patient will receive Dose B of TCK-276 or matching placebo orally from Day 1 to Day 7 (once daily (QD) under fed conditions). Receives: Drug: TCK-276; Drug: TCK-276 Placebo |
| Cohort 3 | Experimental | The patient will receive Dose C of TCK-276 or matching placebo orally from Day 1 to Day 7 (once daily (QD) under fed conditions). Receives: Drug: TCK-276; Drug: TCK-276 Placebo |
| Cohort 4 | Experimental | The patient will receive Dose D of TCK-276 or matching placebo orally from Day 1 to Day 7 (once daily (QD) under fed conditions). Receives: Drug: TCK-276; Drug: TCK-276 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 42 days (duration of study)
Secondary outcomes (18)
Cmax: Plasma Concentrations of TCK-276 and TEI-W00595 (Metabolite)
Cmax: Plasma Concentrations of TCK-276 and TEI-W00595 with time-concentration profile
Measured: Day 1 and Day 7
Tmax: Time of Maximum Plasma Concentration Determined Directly From the Concentration-time Profile
To evaluate tmax as pharmacokinetic (PK) variables of TCK-276 and its metabolite in patients with RA after multiple ascending dose (MAD) administration
Measured: Day 1 and Day 7
t½: Terminal Elimination Half-life
To evaluate t½ as PK variables of TCK-276 and its metabolite in patients with RA after multiple ascending dose (MAD) administration
Measured: Day 1 and Day 7
AUCtau: Area Under the Plasma Concentration-time Curve Over a Dosing Interval, Tau = 24 Hours
To evaluate AUCtau as PK variables of TCK-276 and its metabolite in patients with RA after multiple ascending dose (MAD) administration
Measured: Day 1 and Day 7
AUC0-inf: Area Under the Plasma Concentration Time Curve From Pre-dose (Time 0) Extrapolated to Infinite Time
AUC0-inf:Area under the plasma concentration time curve from pre-dose (time 0) extrapolated to infinite time (Days 1 and 7)
Measured: Day 1 and Day 7
Clearance (CL)/F: Apparent Total Body Clearance (Parent Only)
To evaluate CL/F as PK variables of TCK-276 in patients with RA after multiple ascending dose (MAD) administration
Measured: Day 1 and Day 7
Vz/F: Apparent Volume of Distribution Based on Terminal Phase (Parent Only)
To evaluate Vz/F as PK variables of TCK-276 in patients with RA after multiple ascending dose (MAD) administration
Measured: Day 1 and Day 7
MRT0-inf: Mean Residence Time Extrapolated to Infinity
To evaluate MRT0-inf as PK variables of TCK-276 and its metabolite in patients with RA after multiple ascending dose (MAD) administration
Measured: Day 1 and Day 7
Racc (Cmax): Accumulation Ratio Based on Cmax
Racc (Cmax) calculated as Cmax on Day 7/Cmax on Day 1.
Measured: Day 1 and Day 7
Racc (AUCtau): Accumulation Ratio Based on AUCtau
Racc (AUCtau) calculated as AUCtau on Day 7/AUCtau on Day 1. To evaluate Racc (AUCtau) as PK variables of TCK-276 and its metabolite in patients with RA after multiple ascending dose (MAD) administration
Measured: Day 1 and Day 7
Metabolic Ratio (MR) for Cmax
Molar metabolic ratio of Cmax calculated as (Cmax [metabolite] × molecular weight of parent)/(Cmax [parent] × molecular weight of metabolite).
Measured: Day 1 and Day 7
MR for Area Under the Plasma Concentration-time Curve (AUC)Tau
Molar metabolic ratio of AUC calculated as (AUC [metabolite] × molecular weight of parent)/(AUC [parent] × molecular weight of metabolite). To evaluate MR AUC as PK variables of TCK-276 and its metabolite in patients with RA after multiple ascending dose (MAD) administration
Measured: Day 1 and Day 7
MR for Area Under the Plasma Concentration-time Curve (AUC)0-inf
Molar metabolic ratio of AUC calculated as (AUC [metabolite] × molecular weight of parent)/(AUC [parent] × molecular weight of metabolite) 0-inf. To evaluate MR AUC 0-inf as PK variables of TCK-276 and its metabolite in patients with RA after multiple ascending dose (MAD) administration
Measured: Day 1 and Day 7
Ae 0-24: Amount of Study Drug Excreted Unchanged in the Urine (Days 1 and 7)
Ae 0-24: Amount of study drug excreted unchanged in the urine (Days 1 and 7) over 24 hours
Measured: Day 1 and Day 7
Fe 0-24: Percentage of Study Drug Excreted Unchanged in the Urine (Days 1 and 7)
Fe 0-24: Percentage of study drug excreted unchanged in the urine (Days 1 and 7) over 24 hours
Measured: Day 1 and Day 7
Clearance Renal (CLr): Renal Clearance (Days 1 and 7)
CLr: Renal clearance Day 1 and Day 7 (24 hours)
Measured: Day 1 and Day 7
Ae 0-72: Amount of Study Drug Excreted Unchanged in the Urine (Day 7)
Ae 0-72: Amount of study drug excreted unchanged in the urine (Day 7) over a 72 hour period
Measured: Day 7 0-72 hours
Fe 0-72: Percentage of Study Drug Excreted Unchanged in the Urine
Fe 0-72: Percentage of study drug excreted unchanged in the urine on Day 7 (72 hours)
Measured: Day 7 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start10 Aug 2022
- Primary completion20 Jul 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teijin America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Tatyana Zubkovskaya, Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437419
- Sponsor's protocol ID
- TCK-276-102
- Status last verified
- Oct 2024
- First submitted
- 23 Jun 2022
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 39002122
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05437419
- Acronym / sponsor ID
- TCK-276-102
- Conditions
- Rheumatoid Arthritis
- Keywords
- Multiple Ascending Dose, autoimmune disease, Disease modifying antirheumatic drugs (DMARD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Teijin America, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled, multiple ascending dose (MAD) study.
The study will consist of a Screening Visit (Days -1 to Day 10), Treatment duration (up to 11 days) and a Follow-up/end of treatment (EOT) visit.
This MAD study will consist of 4 cohorts of 8 patients (6 active treatment and 2 matching placebo, or a 3:1 ratio), each receiving an oral dose of TCK-276 or matching placebo for 7 days (once daily (QD) under fed condition). The first cohort will be divided into 2 subgroups to implement the sentinel dosing approach.
The study duration is approximately 42 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: TCK-276, Drug: TCK-276 PlaceboThe 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 | Experimental | Drug: TCK-276, Drug: TCK-276 PlaceboThe 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 | Experimental | Drug: TCK-276, Drug: TCK-276 PlaceboThe 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 | Experimental | Drug: TCK-276, Drug: TCK-276 PlaceboThe patient will receive Dose D of TCK-276 or matching placebo orally from Day 1 to Day 7 (once daily (QD) under fed conditions). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (35 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCK-276Also: Cyclin Dependent Kinase 4/6 (CDK 4/6) Inhibitor, TEI-T01276Patients will receive an oral dose of TCK-276 QD under fed conditions from Day 1 to Day 7. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| TCK-276 PlaceboAlso: PlaceboPatients will receive an oral dose of TCK-276 matching placebo QD under fed conditions from Day 1 to Day 7. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Number ot Participants With Treatment Emergent Adverse Events
Time frame: 42 days (duration of study)
To evaluate the safety and tolerability of multiple oral doses of TCK-276 or placebo in patients with rheumatoid arthritis (RA)
18 secondary outcomes
Cmax: Plasma Concentrations of TCK-276 and TEI-W00595 (Metabolite)
Time frame: Day 1 and Day 7
Tmax: Time of Maximum Plasma Concentration Determined Directly From the Concentration-time Profile
Time frame: Day 1 and Day 7
t½: Terminal Elimination Half-life
Time frame: Day 1 and Day 7
AUCtau: Area Under the Plasma Concentration-time Curve Over a Dosing Interval, Tau = 24 Hours
Time frame: Day 1 and Day 7
AUC0-inf: Area Under the Plasma Concentration Time Curve From Pre-dose (Time 0) Extrapolated to Infinite Time
Time frame: Day 1 and Day 7
Clearance (CL)/F: Apparent Total Body Clearance (Parent Only)
Time frame: Day 1 and Day 7
Vz/F: Apparent Volume of Distribution Based on Terminal Phase (Parent Only)
Time frame: Day 1 and Day 7
MRT0-inf: Mean Residence Time Extrapolated to Infinity
Time frame: Day 1 and Day 7
Racc (Cmax): Accumulation Ratio Based on Cmax
Time frame: Day 1 and Day 7
Racc (AUCtau): Accumulation Ratio Based on AUCtau
Time frame: Day 1 and Day 7
Metabolic Ratio (MR) for Cmax
Time frame: Day 1 and Day 7
MR for Area Under the Plasma Concentration-time Curve (AUC)Tau
Time frame: Day 1 and Day 7
MR for Area Under the Plasma Concentration-time Curve (AUC)0-inf
Time frame: Day 1 and Day 7
Ae 0-24: Amount of Study Drug Excreted Unchanged in the Urine (Days 1 and 7)
Time frame: Day 1 and Day 7
Fe 0-24: Percentage of Study Drug Excreted Unchanged in the Urine (Days 1 and 7)
Time frame: Day 1 and Day 7
Clearance Renal (CLr): Renal Clearance (Days 1 and 7)
Time frame: Day 1 and Day 7
Ae 0-72: Amount of Study Drug Excreted Unchanged in the Urine (Day 7)
Time frame: Day 7 0-72 hours
Fe 0-72: Percentage of Study Drug Excreted Unchanged in the Urine
Time frame: Day 7 0-72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39002122Tasaki 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.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatyana Zubkovskaya study director
Medical Director
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TCK-276 in people with Rheumatoid Arthritis, run by Teijin America, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number ot Participants With Treatment Emergent Adverse Events (time frame: 42 days (duration of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05437419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.