Healthy VolunteersPhase 1NCT03873324
Safety and Pharmacokinetics Study of CPL500036 Compound in Healthy Volunteers
A Phase 1 study testing CPL500036 compound in people with Healthy Volunteers, run by Celon Pharma SA at 1 site in Poland.
Trial summary
The planned study is to determine the safety and pharmacokinetic properties of CPL500036 compound after single and multiple (two weeks) administration in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CPL500036 compound
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 sitePoland
- Study dates
- 20 Dec 2018to 16 Sep 2019
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian female or male,
- Age: 18-55 years old, inclusive,
- Body-mass index (BMI): ≥18.5 kg/m^2 and <29.9 kg/m^2,
- Non-smoker and nonuser of tobacco products for at least 3 months before screening,
- Physical examination without any clinically relevant abnormality,
- Laboratory values not clinically significant,
- Volunteer (or his/her partner) of childbearing potential willingness to use acceptable forms of contraception.
Who cannot join
- Known allergy or hypersensitivity to other drugs similar in structure or class to CPL500036 compound, or to any excipients of the formulation,
- Any known significant current or past acute or chronic disease or condition,
- Participation in other clinical trial within 90 days preceding the screening,
- Blood drawn within 30 days prior to inclusion to the study (more or equal to 300mL),
- Positive results from pregnancy test for female participants,
- Lactation in women participants,
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- Hypotension or hypertension in medical history,
- Long QT interval syndrome or is under the treatment with antiarrhythmic drugs,
- Narcotic, alcohol addiction or abuse,
- Participant who adhere to a special diet (e.g. low calories, vegetarian).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One Centre Single Ascending Dose and Double Blind Multiple Ascending Dose, Safety and Pharmacokinetics Phase I Study of CPL500036 Compound in Healthy Volunteers
The planned study is to determine the safety and pharmacokinetic properties of CPL500036 compound after single and multiple (two weeks) administration in healthy volunteers.
Read the detailed description
This is to be one-centre, single ascending dose and double-blind multiple ascending dose two part study of CPL500036 compound in healthy volunteers.
PART A is a single dose, open-label part with CPL500036 compound administered with dose escalation between cohorts.
PART B is a multiple, double-blind part with CPL500036 compound administered for 14 days with dose escalation between cohorts. Participants in this part are to be randomized to receive Investigational Medicinal Product (IMP) or placebo in 3:1 ratio.
Safety and pharmacokinetic properties of CPL500036 compound is to be determined following different doses in single oral IMP administration in PART A and different doses of IMP administered orally for two weeks in PART B.
- Conditions
- Healthy Volunteers
- Being tested
- CPL500036 compound, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPL500036 compoundDrug
IMP is a capsule with CPL500036 as an Active Pharmaceutical Ingredient (API).
PlaceboDrug
matching placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| CPL500036 | Experimental | PART A: 7 cohorts are to receive single dose of IMP. Each participant is to take single dose of IMP. There is to be dose escalation between cohorts.
PART B: 4 cohorts are to receive multiple dose of IMP. Each participant is to take IMP once daily for 14 days. There is to be dose escalation between cohorts. Receives: Drug: CPL500036 compound |
| Placebo | Placebo comparator | PART B: 2 Participants from 4 cohorts (total of 8 people) are to receive masking placebo capsules once daily for 14 days. There is to be dose escalation between cohorts. Participants are to be randomized within cohorts. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of maximum tolerated dose (MTD) or administration of the maximum dose provided in the protocol after single and multiple oral administration of IMP.
MTD is defined as the highest dose for which no more than 1 of the 6 treated volunteers (less than 1/3) exhibits dose limiting toxicity (DLT).
Measured: up to 24 hours after single administration of IMP in PART A and up to 24 hours after the last IMP administration in PART B
Safety and tolerability of IMP after single and multiple oral administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring.
Participants are to be closely observed to assure maximal safety and to collect occurrence of all adverse events. All participants are to be monitored for clinically relevant changes in physical examination, vital signs, 12-lead ECG assessment and deviations from normal in clinical laboratory results (complete blood count, blood chemistry, urinalysis). To follow-up on all study participants telephone calls with a request for information regarding their health condition are to be made.
Measured: up to 14 days in PART A and up to 28 days in PART B of the study
Secondary outcomes (13)
Cmax - maximum CPL500036 plasma concentration
The maximum concentration of the CPL500036 compound in plasma after IMP administration, obtained directly from the measured concentrations.
Measured: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
AUC(0-72) - area under the plasma concentration - time curve from time 0 to 72h after IMP administration for CPL500036
The AUC(0-72) is a measure of total plasma exposure to the drug from time point zero to 72 hours after IMP administration.
Measured: up to 72 hours after administration of IMP in PART A
AUC(0-24) - area under the plasma concentration - time curve from time 0 to 24h after IMP administration for CPL500036
The AUC(0-24) is a measure of total plasma exposure to the drug from time point zero to 24 hours after IMP administration.
Measured: up to 24 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 and 14 in PART B
AUC(0-inf) - area under the plasma concentration - time curve from time 0 to infinity time for CPL500036
The AUC(0-inf) is a measure of total plasma exposure to the drug from time point zero extrapolated to infinity.
Measured: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
Tmax - time to reach maximum CPL500036 concentration
The Tmax is time to reach the maximum plasma concentration (Cmax), obtained directly from the actual sampling times.
Measured: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
Kel - terminal elimination rate constant
Kel is to be estimated via linear regression of time versus log of concentration.
Measured: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
T1/2 - The plasma elimination half-life for CPL500036 compound
T1/2 is to be calculated as 0.693/Kel.
Measured: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
C (1,t) - CPL500036 concentration
The concentration of CPL500036 on day t before product administration.
Measured: Determined on Day 2, 3, 4, 5, 6, 8, 9, 10, 11, 12 and 13 in PART B.
C (Tmax, t) - CPL500036 concentration
The concentration on day t measured on time Tmax which was calculated in PART A of the study.
Measured: Determined on Day 2, 3, 4, 5, 6, 8, 9, 10, 11, 12 and 13 in PART B.
Amount of CPL500036 in each urine collection sample
It is to be calculated as CPL500036 concentration in urine sample times volume of urine collection.
Measured: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
Ae - total amount of CPL500036 excreted in urine
Ae is to be calculated as asymptote of the plot of the cumulative amount of drug excreted after each collection interval plotted against the median of the collection interval.
Measured: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
Clr - renal clearance
Clr is to be calculated by linear least squares regression analysis on semi-logarithmic transformed data (CLr = excretion rate/C).
Measured: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
Excretion rate
Excretion rate calculated as = CLr/V x Dose x exp(-kt)
Measured: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start20 Dec 2018
- Primary completion16 Sep 2019
- Study completion16 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celon Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873324
- Sponsor's protocol ID
- 01PDE2018
- Status last verified
- Oct 2019
- First submitted
- 11 Mar 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Centre Single Ascending Dose and Double Blind Multiple Ascending Dose, Safety and Pharmacokinetics Phase I Study of CPL500036 Compound in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03873324
- Acronym / sponsor ID
- 01PDE2018
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Celon Pharma SAIndustry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 16 Sep 2019 (actual)
- Study completion
- 16 Sep 2019 (actual)
- First posted
- 13 Mar 2019 (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.
The planned study is to determine the safety and pharmacokinetic properties of CPL500036 compound after single and multiple (two weeks) administration in healthy volunteers.
Detailed description
This is to be one-centre, single ascending dose and double-blind multiple ascending dose two part study of CPL500036 compound in healthy volunteers.
PART A is a single dose, open-label part with CPL500036 compound administered with dose escalation between cohorts.
PART B is a multiple, double-blind part with CPL500036 compound administered for 14 days with dose escalation between cohorts. Participants in this part are to be randomized to receive Investigational Medicinal Product (IMP) or placebo in 3:1 ratio.
Safety and pharmacokinetic properties of CPL500036 compound is to be determined following different doses in single oral IMP administration in PART A and different doses of IMP administered orally for two weeks in PART B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPL500036 | Experimental | Drug: CPL500036 compoundPART A: 7 cohorts are to receive single dose of IMP. Each participant is to take single dose of IMP. There is to be dose escalation between cohorts. PART B: 4 cohorts are to receive multiple dose of IMP. Each participant is to take IMP once daily for 14 days. There is to be dose escalation between cohorts. |
| Placebo | Placebo comparator | Drug: PlaceboPART B: 2 Participants from 4 cohorts (total of 8 people) are to receive masking placebo capsules once daily for 14 days. There is to be dose escalation between cohorts. Participants are to be randomized within cohorts. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Caucasian female or male,
- Age: 18-55 years old, inclusive,
- Body-mass index (BMI): ≥18.5 kg/m^2 and <29.9 kg/m^2,
- Non-smoker and nonuser of tobacco products for at least 3 months before screening,
- Physical examination without any clinically relevant abnormality,
Key exclusion criteria (10 listed)
- Known allergy or hypersensitivity to other drugs similar in structure or class to CPL500036 compound, or to any excipients of the formulation,
- Any known significant current or past acute or chronic disease or condition,
- Participation in other clinical trial within 90 days preceding the screening,
- Blood drawn within 30 days prior to inclusion to the study (more or equal to 300mL),
- Positive results from pregnancy test for female participants,
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 |
|---|---|---|
| CPL500036 compoundIMP is a capsule with CPL500036 as an Active Pharmaceutical Ingredient (API). | Drug | CPL500036 |
| Placebomatching placebo capsules | Drug | Placebo |
Primary outcome
Determination of maximum tolerated dose (MTD) or administration of the maximum dose provided in the protocol after single and multiple oral administration of IMP.
Time frame: up to 24 hours after single administration of IMP in PART A and up to 24 hours after the last IMP administration in PART B
MTD is defined as the highest dose for which no more than 1 of the 6 treated volunteers (less than 1/3) exhibits dose limiting toxicity (DLT).
Safety and tolerability of IMP after single and multiple oral administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring.
Time frame: up to 14 days in PART A and up to 28 days in PART B of the study
Participants are to be closely observed to assure maximal safety and to collect occurrence of all adverse events. All participants are to be monitored for clinically relevant changes in physical examination, vital signs, 12-lead ECG assessment and deviations from normal in clinical laboratory results (complete blood count, blood chemistry, urinalysis). To follow-up on all study participants telephone calls with a request for information regarding their health condition are to be made.
13 secondary outcomes
Cmax - maximum CPL500036 plasma concentration
Time frame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
AUC(0-72) - area under the plasma concentration - time curve from time 0 to 72h after IMP administration for CPL500036
Time frame: up to 72 hours after administration of IMP in PART A
AUC(0-24) - area under the plasma concentration - time curve from time 0 to 24h after IMP administration for CPL500036
Time frame: up to 24 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 and 14 in PART B
AUC(0-inf) - area under the plasma concentration - time curve from time 0 to infinity time for CPL500036
Time frame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
Tmax - time to reach maximum CPL500036 concentration
Time frame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
Kel - terminal elimination rate constant
Time frame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
T1/2 - The plasma elimination half-life for CPL500036 compound
Time frame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
C (1,t) - CPL500036 concentration
Time frame: Determined on Day 2, 3, 4, 5, 6, 8, 9, 10, 11, 12 and 13 in PART B.
C (Tmax, t) - CPL500036 concentration
Time frame: Determined on Day 2, 3, 4, 5, 6, 8, 9, 10, 11, 12 and 13 in PART B.
Amount of CPL500036 in each urine collection sample
Time frame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
Ae - total amount of CPL500036 excreted in urine
Time frame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
Clr - renal clearance
Time frame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
Excretion rate
Time frame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
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 4 Oct 2019.
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Screening Protocol
Pain
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 CPL500036 compound in people with Healthy Volunteers, run by Celon Pharma SA at 1 site in Poland.
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 7 inclusion and 10 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 4 Oct 2019. 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 Poland. 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. 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 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?
Determination of maximum tolerated dose (MTD) or administration of the maximum dose provided in the protocol after single and multiple oral administration of IMP. (time frame: up to 24 hours after single administration of IMP in PART A and up to 24 hours after the last IMP administration in PART B). 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 4 Oct 2019.