Drug Drug InteractionPhase 1NCT05238948
CKD-506 Drug-Drug Interaction Study in Healthy Male Subjects
A Phase 1 study testing Midazolam and CKD-506 in people with Drug Drug Interaction, run by Chong Kun Dang Pharmaceutical at 1 site in Netherlands.
Trial summary
This will be a Phase 1, open-label, 1-sequence crossover drug-drug-interaction study in 16 healthy male subjects to assess the effect of single and multiple doses of CKD-506 on the single-dose PK of oral midazolam. Midazolam will be used as a cytochrome P450 (CYP)3A4 substrate in this study. Read more about this study
- Who is it for?
- Ages 20 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Drug Interaction
- What is being tested?
- Midazolam and CKD-506
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Feb 2022to 29 Apr 2022
- 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 20 to 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects
- Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks)
- Ability and willingness to abstain from foods and beverages containing grapefruit, Seville oranges, pomelos, star fruit, or cranberries
Who cannot join
- History of relevant drug and/or food allergies.
- Using tobacco products
- Positive drug and alcohol screen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, 1-sequence Crossover Drug-drug-interaction Study to Assess the Effect of Single and Multiple Doses of CKD-506 on the Single-Dose Pharmacokinetics of Midazolam, A CYP3A4 Substrate, in Healthy Male Subjects
This will be a Phase 1, open-label, 1-sequence crossover drug-drug-interaction study in 16 healthy male subjects to assess the effect of single and multiple doses of CKD-506 on the single-dose PK of oral midazolam. Midazolam will be used as a cytochrome P450 (CYP)3A4 substrate in this study.
- Conditions
- Drug Drug Interaction
- Being tested
- Midazolam, CKD-506
- Keywords
- CYP3A4, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called Single dose
Substrate of CYP3A4
CKD-506Drug
Also called Single and multiple dose
Perpetrator of CYP3A4
| Study group | Role | What they receive |
|---|---|---|
| Midazolam with/without CKD-506 | Experimental | Single arm and 1-sequence crossover Receives: Drug: Midazolam; Drug: CKD-506 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of oral midazolam
With and without coadministration of CKD-506
Measured: For 24 hours
Area Under Curve (AUC) of oral midazolam
With and without coadministration of CKD-506
Measured: For 24 hours
Secondary outcomes (5)
Cmax of CKD-506 and its metabolites following oral single and multiple doses of CKD-506
Measured: For 24 hours
AUC of CKD-506 and its metabolites following oral single and multiple doses of CKD-506
Measured: For 24 hours
Time to Maximum Plasma Concentration (Tmax) of CKD-506 and its metabolites following oral single and multiple doses of CKD-506
Measured: For 24 hours
Number of treatment emergent adverse events
assessed by clinical laboratory, vital signs, 12-lead electrocardiogram, and physical examination
Measured: Over 4 weeks
Number of participants with treatment emergent adverse events
assessed by clinical laboratory, vital signs, 12-lead electrocardiogram, and physical examination
Measured: Over 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start28 Feb 2022
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Drug InteractionStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- One arm and 1-sequence crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Velinova,, MD, PhD, Principal investigator, PRA Group BV, a PRA Health Sciences company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238948
- Sponsor's protocol ID
- A82_04DDI2124
- Other IDs
- 2021-006496-41
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 25 Aug 2022
- 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 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, 1-sequence Crossover Drug-drug-interaction Study to Assess the Effect of Single and Multiple Doses of CKD-506 on the Single-Dose Pharmacokinetics of Midazolam, A CYP3A4 Substrate, in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05238948
- Acronym / sponsor ID
- A82_04DDI2124
- Conditions
- Drug Drug Interaction
- Keywords
- CYP3A4, Midazolam
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 14 Feb 2022 (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 will be a Phase 1, open-label, 1-sequence crossover drug-drug-interaction study in 16 healthy male subjects to assess the effect of single and multiple doses of CKD-506 on the single-dose PK of oral midazolam. Midazolam will be used as a cytochrome P450 (CYP)3A4 substrate in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One arm and 1-sequence crossover
| Arm | Type | Receives |
|---|---|---|
| Midazolam with/without CKD-506 | Experimental | Drug: Midazolam, Drug: CKD-506Single arm and 1-sequence crossover |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects
- Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks)
- Ability and willingness to abstain from foods and beverages containing grapefruit, Seville oranges, pomelos, star fruit, or cranberries
Key exclusion criteria (3 listed)
- History of relevant drug and/or food allergies.
- Using tobacco products
- Positive drug and alcohol screen
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 |
|---|---|---|
| MidazolamAlso: Single doseSubstrate of CYP3A4 | Drug | Midazolam with/without CKD-506 |
| CKD-506Also: Single and multiple dosePerpetrator of CYP3A4 | Drug | Midazolam with/without CKD-506 |
Primary outcome
Maximum Plasma Concentration (Cmax) of oral midazolam
Time frame: For 24 hours
With and without coadministration of CKD-506
Area Under Curve (AUC) of oral midazolam
Time frame: For 24 hours
With and without coadministration of CKD-506
5 secondary outcomes
Cmax of CKD-506 and its metabolites following oral single and multiple doses of CKD-506
Time frame: For 24 hours
AUC of CKD-506 and its metabolites following oral single and multiple doses of CKD-506
Time frame: For 24 hours
Time to Maximum Plasma Concentration (Tmax) of CKD-506 and its metabolites following oral single and multiple doses of CKD-506
Time frame: For 24 hours
Number of treatment emergent adverse events
Time frame: Over 4 weeks
Number of participants with treatment emergent adverse events
Time frame: Over 4 weeks
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 25 Aug 2022.
- 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.
Maria Velinova,, MD, PhD principal investigator
PRA Group BV, a PRA Health Sciences company
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 Midazolam and CKD-506 in people with Drug Drug Interaction, run by Chong Kun Dang Pharmaceutical at 1 site in Netherlands.
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 3 inclusion and 3 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 25 Aug 2022. 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 Netherlands. 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?
Maximum Plasma Concentration (Cmax) of oral midazolam (time frame: For 24 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 25 Aug 2022.