SafetyPhase 1NCT01243502
A Study to Assess the Pharmacokinetics, Safety and Tolerability of CT327 in Healthy Male Volunteers
A Phase 1 study of Safety, run by Creabilis SA.
Trial summary
K-252a is a potent inhibitor of nerve growth factor (NGF) and therefore has the ability to inhibit keratinocyte proliferation. K-252a is strongly lipophilic and therefore passes freely into the cell membranes of keratinocytes and accumulates at a systemic level. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Safety
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Nov 2007
- 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 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory and other tests.
- The subject is a Caucasian male (Caucasian is defined as having origins in the original peoples of Europe, the Middle East, Western Russia, Afghanistan, or the white racial groups of Africa).
- The subject has a body mass index within the range 19 - 30 kg/m2 and has a weight of ≥ 50 kg.
- The subject is capable of giving informed consent and complying with the restrictions and requirements of the protocol.
- The subject is available to complete the study.
- The subject has been registered with a UK General Practitioner (GP) for 3 months prior to the screening visit.
- A signed and dated consent form has been obtained from the subject in accordance with International Conference on Harmonisation Good Clinical Practice (ICH GCP).
Who cannot join
- As a result of the medical screening process, the PI or medical delegate considers the subject unfit for the study.
- The subject has significant scars, cuts, wounds, dermal abnormalities, tattoos or naevi in the test areas.
- The subject has a past history of contact dermatitis, psoriasis or keloid.
- The subject has any clinically significant abnormality, in the opinion of the PI, on 12-lead ECGs (including subjects with baseline QTcB > 430 ms) at screening.
- The subject has a history of drug or other allergy that contraindicates his participation.
- The subject has participated in a study with a new molecular entity within 4 months, or any other drug trial within 3 months of dosing with the investigational medicinal product (IMP) or placebo.
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- The subject has donated a unit of blood (450 mL) in the 3 months prior to dosing or intends to donate in the month after the last scheduled study visit.
- The subject is currently taking a regular course of medication (including vitamins and herbal remedies).
- The subject regularly, or on average, drinks more than 21 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 125 mL of wine or 20 mL of spirits).
- The subject smokes more than five cigarettes (on average) per day, or has been a smoker of more than 5 cigarettes (on average) per day within the 3 months prior to screening.
- The subject has tested positive for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies.
- The subject has a history of drug abuse or has tested positive for drugs of abuse at pre-study screening. The subject has a positive screen for alcohol and / or drugs of abuse on admission prior to the first dose.
- The subject has consumed methylxanthine-containing food or beverages (e.g. coffee, tea, cola, chocolate, "powerdrinks", caffeine-containing cold remedies) in the 72 h prior to drug administration.
- The subject has used any prescription medication within 2 weeks or 5 half-lives (whichever is longer) of dosing.
- The subject has used non-prescription medication (e.g. aspirin, vitamins and herbal and dietary supplements) within 7 days prior to dosing, or 14 days if the medication contains grapefruit / grapefruit juice or St John's Wort.
- The subject (including those who have had a vasectomy) does not agree to use barrier contraception (condoms) when engaging in sexual activity with women of child bearing potential during the study and for 90 days after completion of the study.
About this study
Official title: A Multiple Dose, Placebo Controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Topically Administered CT327 in Healthy Male Volunteers
K-252a is a potent inhibitor of nerve growth factor (NGF) and therefore has the ability to inhibit keratinocyte proliferation. K-252a is strongly lipophilic and therefore passes freely into the cell membranes of keratinocytes and accumulates at a systemic level. In order to reduce the dermal absorption and reduce the possible long-term systemic toxicity this study will assess a PEGylated derivative of K-252a named CT327. This approach should improve the safety profile of the K-252a molecule while maintaining its activity. The primary objective is to assess the safety and tolerability of single and repeat doses of CT327 when applied topically to the skin of healthy male volunteers.
The secondary objective is to evaluate the eventual systemic absorption (pharmacokinetics; PK) of CT327 following single and repeat doses in healthy male subjects.
- Conditions
- Safety
- Being tested
- 0.01% CT327 (or placebo), 0.001% CT327 (or placebo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.01% CT327 (or placebo)Drug
Cream (10 g) was applied at an even thickness over a test area on the back of 10 x 10 cm to give an exposure of 1000 μg/dm2.
0.001% CT327 (or placebo)Drug
Cream (10 g) was applied at an even thickness over a test area on the back of 10 x 10 cm to give an exposure of 100 μg/dm2.
| Study group | Role | What they receive |
|---|---|---|
| 0.01% CT327 (or placebo) | Experimental | Six (of eight) subjects received a single topical dose of 0.01% CT327 followed by a 7 day wash-out period. The subjects then received a single topical dose of CT327 on five consecutive days. Two subjects received placebo. Receives: Drug: 0.01% CT327 (or placebo) |
| 0.001% CT327 (or placebo) | Experimental | Six (of eight) subjects received a single topical dose of 0.001% CT327 followed by a 7 day wash-out period. The subjects then received a single topical dose of CT327 on five consecutive days. Two subjects received placebo. Receives: Drug: 0.001% CT327 (or placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as defined by local tolerability, subject incidence of TEAEs, and clinically significant changes in lab safety tests, ECGs, vital signs and PE findings.
Each subject received a single topical dose of CT327 (or placebo) followed by a single topical dose of CT327 (or placebo) on five consecutive days with a washout period of 7 days between the two dosing periods.
Measured: 2 weeks
Secondary outcomes (1)
Pharmacokinetic
The secondary endpoint is determination of eventual CT327 plasma levels. PK blood sampling day 1: 0 h, 2 h, 4 h, 6 h, 12 h, 24 h, and 2 h post dose on days 9, 10, 11, 12 and 13.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startSep 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creabilis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LCG Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243502
- Sponsor's protocol ID
- 2114/06-CT327
- Status last verified
- Nov 2010
- First submitted
- 17 Nov 2010
- Last updated
- 18 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose, Placebo Controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Topically Administered CT327 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01243502
- Acronym / sponsor ID
- 2114/06-CT327
- Conditions
- Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Creabilis SAIndustry (pharma, biotech, devices)
- Collaborators
- LCG Bioscience
- Study start
- Sep 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 18 Nov 2010 (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.
K-252a is a potent inhibitor of nerve growth factor (NGF) and therefore has the ability to inhibit keratinocyte proliferation. K-252a is strongly lipophilic and therefore passes freely into the cell membranes of keratinocytes and accumulates at a systemic level. In order to reduce the dermal absorption and reduce the possible long-term systemic toxicity this study will assess a PEGylated derivative of K-252a named CT327. This approach should improve the safety profile of the K-252a molecule while maintaining its activity. The primary objective is to assess the safety and tolerability of single and repeat doses of CT327 when applied topically to the skin of healthy male volunteers.
The secondary objective is to evaluate the eventual systemic absorption (pharmacokinetics; PK) of CT327 following single and repeat doses in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.01% CT327 (or placebo) | Experimental | Drug: 0.01% CT327 (or placebo)Six (of eight) subjects received a single topical dose of 0.01% CT327 followed by a 7 day wash-out period. The subjects then received a single topical dose of CT327 on five consecutive days. Two subjects received placebo. |
| 0.001% CT327 (or placebo) | Experimental | Drug: 0.001% CT327 (or placebo)Six (of eight) subjects received a single topical dose of 0.001% CT327 followed by a 7 day wash-out period. The subjects then received a single topical dose of CT327 on five consecutive days. Two subjects received placebo. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The subject is free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory and other tests.
- The subject is a Caucasian male (Caucasian is defined as having origins in the original peoples of Europe, the Middle East, Western Russia, Afghanistan, or the white racial groups of Africa).
- The subject has a body mass index within the range 19 - 30 kg/m2 and has a weight of ≥ 50 kg.
- The subject is capable of giving informed consent and complying with the restrictions and requirements of the protocol.
- The subject is available to complete the study.
Key exclusion criteria (16 listed)
- As a result of the medical screening process, the PI or medical delegate considers the subject unfit for the study.
- The subject has significant scars, cuts, wounds, dermal abnormalities, tattoos or naevi in the test areas.
- The subject has a past history of contact dermatitis, psoriasis or keloid.
- The subject has any clinically significant abnormality, in the opinion of the PI, on 12-lead ECGs (including subjects with baseline QTcB > 430 ms) at screening.
- The subject has a history of drug or other allergy that contraindicates his participation.
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 |
|---|---|---|
| 0.01% CT327 (or placebo)Cream (10 g) was applied at an even thickness over a test area on the back of 10 x 10 cm to give an exposure of 1000 μg/dm2. | Drug | 0.01% CT327 (or placebo) |
| 0.001% CT327 (or placebo)Cream (10 g) was applied at an even thickness over a test area on the back of 10 x 10 cm to give an exposure of 100 μg/dm2. | Drug | 0.001% CT327 (or placebo) |
Primary outcome
Safety as defined by local tolerability, subject incidence of TEAEs, and clinically significant changes in lab safety tests, ECGs, vital signs and PE findings.
Time frame: 2 weeks
Each subject received a single topical dose of CT327 (or placebo) followed by a single topical dose of CT327 (or placebo) on five consecutive days with a washout period of 7 days between the two dosing periods.
1 secondary outcome
Pharmacokinetic
Time frame: 2 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 18 Nov 2010.
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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 study of Safety, run by Creabilis SA.
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 16 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 18 Nov 2010. 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. 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?
Safety as defined by local tolerability, subject incidence of TEAEs, and clinically significant changes in lab safety tests, ECGs, vital signs and PE findings. (time frame: 2 weeks). 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 18 Nov 2010.