HypertensionPhase 1NCT03017950
Pharmacokinetic Drug-drug Interaction of CKD-330 and D086
A Phase 1 study testing CKD-330, D086 and CKD-330 + D086 in people with Hypertension and Hyperlipidemias, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of the study is examining and comparing the pharmacokinetic drug interaction and safety of both single administration and combination administration of CKD-330 and D086 to healthy male subjects 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
- Hypertension, Hyperlipidemias
- What is being tested?
- CKD-330, D086 and CKD-330 + D086
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2016to May 2017
- 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 adult males age of between 19 - 45 on the day of screening.
- Body mass index(BMI) between 18.0 - 29.0 kg/m^2 and weight ≥ 55kg (Body mass index (BMI) = weight (kg) / height (m)^2)
- Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations.
- Not abnormal or not clinically significant lab values.
- Subjects who signed informed consent form with good understandings after explanations by investigators.
Who cannot join
- No history or presence of clinically significant cardiac, respiratory, neurological, endocrine, metal and renal diseases and liver and kidney diseases.
- Subjects showing angioedema as an adverse reaction to ACE inhibitors
- Primary Hyperaldosteronism
- History or family history of myopathy
- Subjects with mental diseases or drug addiction
- Allergic reactions to candesartan or amlodipine or atorvastatin
Show all 19Show fewer
- Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
- Hypotension(SBP ≤100mmHg or DBP≤55mnHg) or hypertension ( SNP ≥ 150mmHg, DBP ≥95mmHg) on the day of screening
- Subjects who experienced gastrointestinal diseases or surgeries which can affect absorption of Investigational product
- Subjects with abnormal lab values at least one below
- (AST or ALT>2 fold of upper normal limit, Total bilirubin>2 fold of upper normal limit, CPK>2 fold of upper normal limit, K <3.5mEq/L or >5.5mEq/L, Estimated Glomerular filtration rate<60mL/min/1.73m2 by Modification)
- Continuous drinking (over 21 units/week, 1 unit= 10g=12.5mL of pure alcohol), heavy smoker(> 10 cigarettes per day) and unable to stop drinking during clinical trials
- Subjects who previously participated in other clinical trials within 90 days
- Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
- Subjects who were administered below medications within 30 days (cyclosporin, erythromycin, clarithromycin, lopinavir, ritonavir, itraconazole, ketoconazole, rifampicin, barbiturate : theses medicines could affect absorption, metabolism, distribution and excretion of candesartan,amlodipine and atorvastatin)
- Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days.
- Subjects who have taken any diets affecting absorption, metabolism, distribution and excretion of investigational products (especially grapefruit juice).
- Subjects who are in conditions impossible participating in the clinical trials following other laboratory tests.
- Unable to use contraceptions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Trial to Evaluate the Pharmacokinetic Drug-drug Interaction of CKD-330 and D086 in Healthy Male Volunteers
The purpose of the study is examining and comparing the pharmacokinetic drug interaction and safety of both single administration and combination administration of CKD-330 and D086 to healthy male subjects
Read the detailed description
An open-label, randomized, multiple-dose, 2-sequence, 2-period, 2-treatment, crossover study
Part1: Examining how D086 affects pharmacokinetics of CKD-330. Part2: Examining how CKD-330 affects pharmacokinetics of D086.
- Conditions
- Hypertension, Hyperlipidemias
- Being tested
- CKD-330, D086, CKD-330 + D086
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-330Drug
D086Drug
CKD-330 + D086Drug
| Study group | Role | What they receive |
|---|---|---|
| Part1 (A) | Experimental | Number of Subjects: 10
Number of days for Period 1: 8
Number of days for Period 2: 8
Number of days for wash-out between period 1 and period 2: 14
IPs for Period 1: CKD-330
IPs for Period 2: CKD-330 + D086 Receives: Drug: CKD-330; Drug: CKD-330 + D086 |
| Part1 (B) | Experimental | Number of Subjects: 10
Number of days for Period 1: 8
Number of days for Period 2: 8
Number of days for wash-out between period 1 and period 2: 14
IPs for Period 1: CKD-330 + D086
IPs for Period 2: CKD-330 Receives: Drug: CKD-330; Drug: CKD-330 + D086 |
| Part2 (A) | Experimental | Number of Subjects: 30
Number of days for Period 1: 8
Number of days for Period 2: 8
Number of days for wash-out between period 1 and period 2: 14
IPs for Period 1: D086
IPs for Period 2: CKD-330 + D086 Receives: Drug: D086; Drug: CKD-330 + D086 |
| Part2 (B) | Experimental | Number of Subjects: 30
Number of days for Period 1: 8
Number of days for Period 2: 8
Number of days for wash-out between period 1 and period 2: 14
IPs for Period 1: CKD-330 + D086
IPs for Period 2: D086 Receives: Drug: D086; Drug: CKD-330 + D086 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ,ss of Candesartan and Amlodipine
Measured: Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30
AUCτ,ss of atorvastatin and 2-hydroxy atorvastatin
Measured: Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionMar 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017950
- Sponsor's protocol ID
- 170DDI16017
- Status last verified
- Jul 2017
- First submitted
- 10 Jan 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Evaluate the Pharmacokinetic Drug-drug Interaction of CKD-330 and D086 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03017950
- Acronym / sponsor ID
- 170DDI16017
- Conditions
- Hypertension, Hyperlipidemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 11 Jan 2017 (estimated)
- 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.
The purpose of the study is examining and comparing the pharmacokinetic drug interaction and safety of both single administration and combination administration of CKD-330 and D086 to healthy male subjects
Detailed description
An open-label, randomized, multiple-dose, 2-sequence, 2-period, 2-treatment, crossover study
Part1: Examining how D086 affects pharmacokinetics of CKD-330. Part2: Examining how CKD-330 affects pharmacokinetics of D086.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part1 (A) | Experimental | Drug: CKD-330, Drug: CKD-330 + D086Number of Subjects: 10 Number of days for Period 1: 8 Number of days for Period 2: 8 Number of days for wash-out between period 1 and period 2: 14 IPs for Period 1: CKD-330 IPs for Period 2: CKD-330 + D086 |
| Part1 (B) | Experimental | Drug: CKD-330, Drug: CKD-330 + D086Number of Subjects: 10 Number of days for Period 1: 8 Number of days for Period 2: 8 Number of days for wash-out between period 1 and period 2: 14 IPs for Period 1: CKD-330 + D086 IPs for Period 2: CKD-330 |
| Part2 (A) | Experimental | Drug: D086, Drug: CKD-330 + D086Number of Subjects: 30 Number of days for Period 1: 8 Number of days for Period 2: 8 Number of days for wash-out between period 1 and period 2: 14 IPs for Period 1: D086 IPs for Period 2: CKD-330 + D086 |
| Part2 (B) | Experimental | Drug: D086, Drug: CKD-330 + D086Number of Subjects: 30 Number of days for Period 1: 8 Number of days for Period 2: 8 Number of days for wash-out between period 1 and period 2: 14 IPs for Period 1: CKD-330 + D086 IPs for Period 2: D086 |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult males age of between 19 - 45 on the day of screening.
- Body mass index(BMI) between 18.0 - 29.0 kg/m^2 and weight ≥ 55kg (Body mass index (BMI) = weight (kg) / height (m)^2)
- Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations.
- Not abnormal or not clinically significant lab values.
- Subjects who signed informed consent form with good understandings after explanations by investigators.
Key exclusion criteria (19 listed)
- No history or presence of clinically significant cardiac, respiratory, neurological, endocrine, metal and renal diseases and liver and kidney diseases.
- Subjects showing angioedema as an adverse reaction to ACE inhibitors
- Primary Hyperaldosteronism
- History or family history of myopathy
- Subjects with mental diseases or drug addiction
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 |
|---|---|---|
| CKD-330 | Drug | Part1 (A), Part1 (B) |
| D086 | Drug | Part2 (A), Part2 (B) |
| CKD-330 + D086 | Drug | Part1 (A), Part1 (B), Part2 (A), Part2 (B) |
Primary outcome
AUCτ,ss of Candesartan and Amlodipine
Time frame: Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30
AUCτ,ss of atorvastatin and 2-hydroxy atorvastatin
Time frame: Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30
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 21 Jul 2017.
- 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.
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 CKD-330, D086 and CKD-330 + D086 in people with Hypertension and Hyperlipidemias, run by Chong Kun Dang Pharmaceutical 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 5 inclusion and 19 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 21 Jul 2017. 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?
AUCτ,ss of Candesartan and Amlodipine (time frame: Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30). 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 21 Jul 2017.