Smoking CessationPhase 1NCT04631874
A Clinical Trial to Compare Pharmacokinetics of the "CDFF0318" and "Champix Tab. 1mg"
A Phase 1 study testing CDFF0318, Champix in people with Smoking Cessation and Pharmacokinetics, run by CTC Bio, Inc. at 1 site in South Korea.
Trial summary
A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics after Administration of the "CDFF0318" and "Champix Tab. 1mg (Varenicline tartrate)" in Healthy Male Volunteers Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Pharmacokinetics
- What is being tested?
- CDFF0318, Champix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jul 2019to 1 May 2020
- Phase
- Phase 1
- 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 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 19 to 45 years
- a body mass index of 18.0-30.0 kg/m2
Who cannot join
- Subjects with disease history or current disease of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood/tumor, urinary system, cardiovascular system, etc.
- Subjects with a history of gastrointestinal diseases or gastrointestinal surgery that may affect the absorption of investigational drugs
- Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing varenicline and other drugs (ketoprofen, aspirin, antibiotics, etc.)
- Subjects who have an abnormal diet that may affect the absorption, distribution, metabolism, and excretion of the drug, or who eat food that may affect drug metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of the "CDFF0318" and "Champix Tab. 1mg (Varenicline Tartrate)" in Healthy Male Volunteers
A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics after Administration of the "CDFF0318" and "Champix Tab. 1mg (Varenicline tartrate)" in Healthy Male Volunteers
- Conditions
- Smoking Cessation, Pharmacokinetics
- Being tested
- CDFF0318, Champix
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDFF0318, ChampixDrug
CDFF0318: Varenicline salt changed Champix: Varenicline tartrate
| Study group | Role | What they receive |
|---|---|---|
| Sequence A(RT) | Experimental | Reference drug (Champix) -> washout -> test drug (CDFF0318) Receives: Drug: CDFF0318, Champix |
| Sequence B(TR) | Experimental | Test drug (CDFF0318) -> washout -> reference drug (Champix) Receives: Drug: CDFF0318, Champix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (AUC0-t)
AUC0-t of "CDFF0318" and "Champix Tab. 1mg"
Measured: 72 hours
Pharmacokinetics (Cmax)
Cmax of "CDFF0318" and "Champix Tab. 1mg"
Measured: 72 hours
Secondary outcomes (8)
Safety and tolerability (Vital sign)
Blood pressure (mmHg)
Measured: 72 hours
Safety and tolerability (Vital sign)
Heart rate (beats/min)
Measured: 72 hours
Safety and tolerability (12-lead ECG)
ventricular rate (beats/min)
Measured: 72 hours
Safety and tolerability (12-lead ECG)
PR interval (msec)
Measured: 72 hours
Safety and tolerability (Laboratory tests)
Creatinine [mg/dL]
Measured: 72 hours
Safety and tolerability (Laboratory tests)
AST, ALT [IU/L]
Measured: 72 hours
Safety and tolerability (Laboratory tests)
eGFR [mL/min/1.73m^2]
Measured: 72 hours
Safety and tolerability (Adverse events)
Adverse events were collected regardless of the time point when the subject complained of symptoms.
Adverse events were assessed by CTCAE v5.0
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start24 Jul 2019
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- CTC Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-Kyu Park, Principal investigator, Chungbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631874
- Sponsor's protocol ID
- CTC-IND-CDFF0318_1
- Status last verified
- Oct 2020
- First submitted
- 27 Oct 2020
- Last updated
- 17 Nov 2020
- Results posted
- 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 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of the "CDFF0318" and "Champix Tab. 1mg (Varenicline Tartrate)" in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT04631874
- Acronym / sponsor ID
- CTC-IND-CDFF0318_1
- Conditions
- Smoking Cessation, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CTC Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 17 Nov 2020 (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.
A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics after Administration of the "CDFF0318" and "Champix Tab. 1mg (Varenicline tartrate)" in Healthy Male Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A(RT) | Experimental | Drug: CDFF0318, ChampixReference drug (Champix) -> washout -> test drug (CDFF0318) |
| Sequence B(TR) | Experimental | Drug: CDFF0318, ChampixTest drug (CDFF0318) -> washout -> reference drug (Champix) |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male subjects aged 19 to 45 years
- a body mass index of 18.0-30.0 kg/m2
Key exclusion criteria (4 listed)
- Subjects with disease history or current disease of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood/tumor, urinary system, cardiovascular system, etc.
- Subjects with a history of gastrointestinal diseases or gastrointestinal surgery that may affect the absorption of investigational drugs
- Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing varenicline and other drugs (ketoprofen, aspirin, antibiotics, etc.)
- Subjects who have an abnormal diet that may affect the absorption, distribution, metabolism, and excretion of the drug, or who eat food that may affect drug metabolism
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 |
|---|---|---|
| CDFF0318, ChampixCDFF0318: Varenicline salt changed Champix: Varenicline tartrate | Drug | Sequence A(RT), Sequence B(TR) |
Primary outcome
Pharmacokinetics (AUC0-t)
Time frame: 72 hours
AUC0-t of "CDFF0318" and "Champix Tab. 1mg"
Pharmacokinetics (Cmax)
Time frame: 72 hours
Cmax of "CDFF0318" and "Champix Tab. 1mg"
8 secondary outcomes
Safety and tolerability (Vital sign)
Time frame: 72 hours
Safety and tolerability (Vital sign)
Time frame: 72 hours
Safety and tolerability (12-lead ECG)
Time frame: 72 hours
Safety and tolerability (12-lead ECG)
Time frame: 72 hours
Safety and tolerability (Laboratory tests)
Time frame: 72 hours
Safety and tolerability (Laboratory tests)
Time frame: 72 hours
Safety and tolerability (Laboratory tests)
Time frame: 72 hours
Safety and tolerability (Adverse events)
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- 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.
Min-Kyu Park principal investigator
Chungbuk National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CDFF0318, Champix in people with Smoking Cessation and Pharmacokinetics, run by CTC Bio, Inc. at 1 site in South Korea.
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 2 inclusion and 4 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 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetics (AUC0-t) (time frame: 72 hours). 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 17 Nov 2020.