Refractory Chronic CoughPhase 1/2NCT06213363
A Phase Ib/II Clinical Study in Patients With Refractory Chronic Cough
A Phase 1/2 study testing TCR1672 tablet in people with Refractory Chronic Cough, run by Beijing Tide Pharmaceutical Co., Ltd.
Trial summary
This study is a multicenter, randomized, double-blind, placebo-controlled Phase Ib/II clinical trial to evaluate the effectiveness, safety, tolerability and pharmacokinetics (PK) of TCR1672 Tablets in patients with refractory chronic cough. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Chronic Cough
- What is being tested?
- TCR1672 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants who can understand and are willing to complete this trial in strict accordance with the clinical trial protocol, and voluntarily sign the informed consent form;
- Age ≥ 18 years (subject to the age specified in the valid document at the time of signing the informed consent form);
- Male participants weighing ≥ 50 kg and female participants weighing ≥ 45 kg, and BMI < 35kg/m2;
- History of chronic cough for more than 1 year, and definitely diagnosed as refractory chronic cough or chronic cough of unknown cause. See Appendix 2 for the diagnostic criteria;
- Chest imaging within 5 years prior to screening and after the onset of chronic cough did not show abnormal changes that in the opinion of the investigator may contribute to the chronic cough;
- The 100-mm cough Visual Analogue Scale (VAS) score ≥ 40 mm at screening and baseline;
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- The cough recorder at screening showed an average of 10 or more coughs per hour while awake;
- Participants of childbearing potential and their sexual partners are willing to take one or more effective non-drug contraceptive measures and have no plans to donate sperm or ova from the time of screening until 6 months after the last dose of study drug; Female participants should be non-pregnant and non-lactating, and should meet at least 1 of the following conditions:
- Not a woman of childbearing potential (WOCBP) as defined in the appendix;
- Is a WOCBP and agrees to follow the contraception requirements in the appendix for the duration of the study and for at least 6 months after the last dose of the study;
- The WOCBP has a negative blood pregnancy test prior to the first dose of study drug;
- If the blood pregnancy result is positive, the participant must be withdrawn from the study;
- Refer to the Study Flow Chart for additional pregnancy testing requirements during and after the study;
- Investigators are responsible for reviewing medical and menstrual history to see whether the requirements for highly effective contraception will be met so as to reduce the risk of including females with early undetected pregnancy.
Who cannot join
- Pre-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) < 70% of the expected value at screening;
- History of upper or lower respiratory tract infection (including bacterial, fungal, viral and other pathogenic microorganism infections) or recent significant change in pulmonary conditions (including acute exacerbation of respiratory disease or significant change in chest imaging) within 4 weeks prior to screening or randomization;
- Diagnosed as chronic obstructive pulmonary disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis (IPF), active pulmonary tuberculosis before screening;
- Past medical history of hypogeusia or taste disorder, or known taste abnormality;
- With malignancy within 5 years prior to screening (except adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ);
- Moderate renal insufficiency: glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 prior to screening or prior to randomization;
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- Moderate to severe hepatic insufficiency (Child-Pugh Class B or C) prior to screening or prior to randomization;
- History of unstable or worsening cardiovascular disease prior to screening or prior to randomization, including but not limited to: unstable angina, myocardial infarction, thromboembolism;
- Those who are smoking or have quitted smoking for less than 1 year, or have a smoking history of annual consumption of more than 20 pack-years at screening;
- Recent (within the past 1 year) history of drug or alcohol abuse or dependence;
- Known hypersensitivity to any ingredient of this medication;
- Systemic or topical use of drugs or foods that may affect the PK characteristics of the study drug, including strong inducers, strong inhibitors or substrates of CYP2C19 and CYP3A, and drinking grapefruit or grapefruit juice within 14 days prior to screening and during the trial (see Table 6 for details);
- Systemic or topical use of antitussive drugs, including opioids, pregabalin, gabapentin, dextromethorphan, traditional Chinese medicine and over-the-counter drugs with antitussive effect, etc., within 4 weeks prior to screening and during the trial [participants are allowed to receive a stable (≥ 4 weeks prior to the first dose of study drug) treatment for cough etiology, including antihistamines, leukotriene receptor antagonists, inhaled or oral glucocorticoids, long-acting bronchodilators, etc., or receive stable (≥ 8 weeks prior to the first dose of study drug) treatment with proton pump inhibitors];
- Receiving an angiotensin converting enzyme inhibitor currently or within 3 months prior to screening;
- Participation in any other clinical study with the last dose of an study drug within 4 weeks prior to screening, or within 5 half-lives at screening (whichever is longer);
- Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at screening and baseline (the test should be performed after resting for at least 5 minutes and the criterion is still met after a repeat examination);
- Family history of long QT syndrome and sudden death, or significant ECG abnormalities at screening, including but not limited to: QTcF interval > 450 ms, atrial fibrillation or flutter, heart rate < 40 beats/min or > 110 beats/min, second or third degree atrioventricular block, left bundle branch block;
- Clinically significant abnormalities in laboratory test results at screening, including but not limited to:
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) or glutamyl transpeptidase (GGT) > 2 times the upper limit of normal, and total bilirubin > 1.5 times the upper limit of normal;
- Creatinine > times the upper limit of normal;
- Coagulation abnormalities including but not limited to abnormal platelet count (< 100 × 103/mm3), prolonged PT or INR ≥ 1.5;
- Positive hepatitis B virus surface antigen, or positive hepatitis B virus core antibody, negative hepatitis B virus surface antibody and positive HBV-DNA, or positive hepatitis C virus antibody or positive HCV-RNA, or positive treponema pallidum antibody, or positive human immunodeficiency virus (HIV) antibody at screening;
- Pregnant or breast-feeding;
- Any past or current acute or chronic illness, psychiatric illness, or laboratory abnormality that, in the judgment of the investigator, may compromise the safety or compliance of the participant, or affect the absorption of the study drug and study assessments, or render the participant unable to complete the study.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ib/II Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetics of TCR1672 Tablets in Patients With Refractory Chronic Cough
This study is a multicenter, randomized, double-blind, placebo-controlled Phase Ib/II clinical trial to evaluate the effectiveness, safety, tolerability and pharmacokinetics (PK) of TCR1672 Tablets in patients with refractory chronic cough.
Read the detailed description
All potential participants proceed to the screening period (7-14 days) after voluntarily signing the informed consent form, and the investigators conduct eligibility assessment for the participants as per the inclusion and exclusion criteria. 72patients with RCC are planned to be enrolled in this study. All participants will firstly be randomized at a ratio of 1:1:1 to receive one of the three oral doses of three times a day TCR1672 (20mg, 40mg, 60mg). Then patients will further be randomized to two treatment sequences, Dosing Sequence 1 and Dosing Sequence 2. Participants in Dosing Sequence 1 will be given TCR1672 Tablets for 1 weeks, followed by a 1-week washout period, and then crossover to 1-week placebo treatment. Participants in Dosing Sequence 2 will be firstly administered 1-week placebo treatment, followed by a 1-week washout period, and then crossover to TCR1672 tablets for 1-week treatment. TCR1672 Tablets will be administered orally after meal. No dose adjustments are allowed during the study.
- Conditions
- Refractory Chronic Cough
- Being tested
- TCR1672 tablet
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCR1672 tabletDrug
All potential participants proceed to the screening period (7-14 days) after voluntarily signing the informed consent form, and the investigators conduct eligibility assessment for the participants as per the inclusion and exclusion criteria. 72patients with RCC are planned to be enrolled in this study. All participants will firstly be randomized at a ratio of 1:1:1 to receive one of the three oral doses of three times a day TCR1672 (20mg, 40mg, 60mg). Then patients will further be randomized to two treatment sequences, Dosing Sequence 1 and Dosing Sequence 2. Participants in Dosing Sequence 1 will be given TCR1672 Tablets for 1 weeks, followed by a 1-week washout period, and then crossover to 1-week placebo treatment. Participants in Dosing Sequence 2 will be firstly administered 1-week placebo treatment, followed by a 1-week washout period, and then crossover to TCR1672 tablets for 1-week treatment.
| Study group | Role | What they receive |
|---|---|---|
| TCR1672 tablet | Experimental | TCR1672 tablet Receives: Drug: TCR1672 tablet |
| TCR1672 placebo | Placebo comparator | TCR1672 placebo Receives: Drug: TCR1672 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Endpoint
Change from baseline in 24-hour cough frequency after 1-week treatment
Measured: 1 week
Safety Endpoints
Severity and incidence of treatment emergent adverse events (TEAEs) from the first dose to the end of follow-up
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study startFeb 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Chronic CoughStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tide Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213363
- Sponsor's protocol ID
- TCR1672-II-01
- Status last verified
- Dec 2023
- First submitted
- 15 Dec 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ib/II Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetics of TCR1672 Tablets in Patients With Refractory Chronic Cough
- ClinicalTrials.gov ID
- NCT06213363
- Acronym / sponsor ID
- TCR1672-II-01
- Conditions
- Refractory Chronic Cough
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Beijing Tide Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter, randomized, double-blind, placebo-controlled Phase Ib/II clinical trial to evaluate the effectiveness, safety, tolerability and pharmacokinetics (PK) of TCR1672 Tablets in patients with refractory chronic cough.
Detailed description
All potential participants proceed to the screening period (7-14 days) after voluntarily signing the informed consent form, and the investigators conduct eligibility assessment for the participants as per the inclusion and exclusion criteria. 72patients with RCC are planned to be enrolled in this study. All participants will firstly be randomized at a ratio of 1:1:1 to receive one of the three oral doses of three times a day TCR1672 (20mg, 40mg, 60mg). Then patients will further be randomized to two treatment sequences, Dosing Sequence 1 and Dosing Sequence 2. Participants in Dosing Sequence 1 will be given TCR1672 Tablets for 1 weeks, followed by a 1-week washout period, and then crossover to 1-week placebo treatment. Participants in Dosing Sequence 2 will be firstly administered 1-week placebo treatment, followed by a 1-week washout period, and then crossover to TCR1672 tablets for 1-week treatment. TCR1672 Tablets will be administered orally after meal. No dose adjustments are allowed during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCR1672 tablet | Experimental | Drug: TCR1672 tabletTCR1672 tablet |
| TCR1672 placebo | Placebo comparator | Drug: TCR1672 tabletTCR1672 placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female participants who can understand and are willing to complete this trial in strict accordance with the clinical trial protocol, and voluntarily sign the informed consent form;
- Age ≥ 18 years (subject to the age specified in the valid document at the time of signing the informed consent form);
- Male participants weighing ≥ 50 kg and female participants weighing ≥ 45 kg, and BMI < 35kg/m2;
- History of chronic cough for more than 1 year, and definitely diagnosed as refractory chronic cough or chronic cough of unknown cause. See Appendix 2 for the diagnostic criteria;
- Chest imaging within 5 years prior to screening and after the onset of chronic cough did not show abnormal changes that in the opinion of the investigator may contribute to the chronic cough;
Key exclusion criteria (24 listed)
- Pre-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) < 70% of the expected value at screening;
- History of upper or lower respiratory tract infection (including bacterial, fungal, viral and other pathogenic microorganism infections) or recent significant change in pulmonary conditions (including acute exacerbation of respiratory disease or significant change in chest imaging) within 4 weeks prior to screening or randomization;
- Diagnosed as chronic obstructive pulmonary disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis (IPF), active pulmonary tuberculosis before screening;
- Past medical history of hypogeusia or taste disorder, or known taste abnormality;
- With malignancy within 5 years prior to screening (except adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ);
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 |
|---|---|---|
| TCR1672 tabletAll potential participants proceed to the screening period (7-14 days) after voluntarily signing the informed consent form, and the investigators conduct eligibility assessment for the participants as per the inclusion and exclusion criteria. 72patients with RCC are planned to be enrolled in this study. All participants will firstly be randomized at a ratio of 1:1:1 to receive one of the three oral doses of three times a day TCR1672 (20mg, 40mg, 60mg). Then patients will further be randomized to two treatment sequences, Dosing Sequence 1 and Dosing Sequence 2. Participants in Dosing Sequence 1 will be given TCR1672 Tablets for 1 weeks, followed by a 1-week washout period, and then crossover to 1-week placebo treatment. Participants in Dosing Sequence 2 will be firstly administered 1-week placebo treatment, followed by a 1-week washout period, and then crossover to TCR1672 tablets for 1-week treatment. | Drug | TCR1672 placebo, TCR1672 tablet |
Primary outcome
Efficacy Endpoint
Time frame: 1 week
Change from baseline in 24-hour cough frequency after 1-week treatment
Safety Endpoints
Time frame: 4 week
Severity and incidence of treatment emergent adverse events (TEAEs) from the first dose to the end of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TCR1672 tablet in people with Refractory Chronic Cough, run by Beijing Tide Pharmaceutical Co., Ltd.
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 14 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Efficacy Endpoint (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2024.