Healthy VolunteersEarly Phase 1NCT02355756
Biomarker Development for Future PAC1 Antagonists With Maxadilan
A Early Phase 1 study testing Maxadilan in people with Healthy Volunteers, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This will be a single center, open-label study in healthy male subjects between 18 and 45 years old to determine the dose response profiles of dermal blood flow in response to intradermal injections of maxadilan. The study will consist of 2 parts: Part I: dose and time finding and Part II: reproducibility over time. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Maxadilan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2015to Apr 2015
- Phase
- Early 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a white male ≥18 and ≤ 45 years of age.
- Subject is a nonsmoker for at least 6 months prior to study start.
- Subject has a body mass index between 18-28 kg/m2.
- Subject is judged to be in good health on the basis of medical history, physical examination, vital signs, electrocardiogram, and routine laboratory data (including complete blood count, complete chemistry panel, prothrombin time and activated partial thromboplastin time (see Appendix C).
- Subjects must agree to practice a highly effective method of birth control during the study and for 1 week after dosing. Highly effective method of birth control includes sexual abstinence, vasectomy, or a condom in combination with hormonal birth control or intrauterine device (female partner).
- Subjects must agree not to donate sperm for the duration of the study.
- Subject understands the procedures and agrees to participate in the study by giving written informed consent.
- Subject agrees to refrain from strenuous physical activity 3 days before the screening visit, each study period and poststudy visit.
Who cannot join
- Subject has a history of any illness (including migraine) or has had/is expected to have surgery within 1 month of the start of the study which, in the investigator's opinion, might confound the results of the study.
- Subject has eczema, scleroderma, psoriasis, dermatitis, or keloids, tumors, ulcers, burns, flaps, or grafts on their forearm or other abnormality of the skin which may interfere with the study assessments.
- Subject has excessive hair growth on volar surface of the forearm.
- Subject cannot avoid excessive tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and cannot cover forearms for 24 hours prior to each treatment period.
- Subject has a history of significant (drug) allergies including adverse experiences of a serious nature related to the administration of either a marketed or investigational drug or allergic reactions related to insect bites
- Subject currently uses any prescription or nonprescription drugs on a regular basis which cannot be discontinued for the duration of the study; subject has used any prescription or nonprescription medication within 14 days of the start of the study.
Show all 16Show fewer
- Subject currently uses lotions, oils, depilatory preparations, or other topical treatments on the arms on a regular basis which cannot be discontinued for the duration of the study; subject has used any topical treatments within 7 days of the start of the study.
- Subject is a habitual and heavy consumer of coffee or caffeinated beverages (more than approximately 4 cups of tea, coffee, or cola drinks/day) at the time of the study. Subjects who have reduced their consumption to 4 cups of coffee/day at least 1 week prior to enrollment may participate. Subjects who cannot restrain from caffeinated beverages 12 hours before the study visit.
- Subject is unable to refrain from drinking alcohol 24 hours prior to maxadilan dosing, is currently a regular user (including "recreational use") of any illicit drugs, or has a history of drug (including alcohol) abuse.
- Subject has a positive urine drug test or alcohol breath test at screening or predose in period 1. The drug screens will include amphetamines / methamphetamines, methylenedioxymethamphetamine, benzodiaze-pines, barbiturates, cocaine, cannabis, tricyclic antidepressants, methadone and opiates.
- Subject is a smoker, cannot refrain from being around second hand smoke 24 hours prior to maxadilan dosing, or uses nicotine-containing products. Ex-smokers should have ceased smoking at least 6 months prior to screening. Nonsmokers will be confirmed by negative urinary cotinine tests at screening and predose period 1.
- Subject has any of the following vital sign measurements at screening: Heart Rate <40 or >100 beats/min, Diastolic Blood Pressure <50 or >89 mmHg, Systolic Blood Pressure <90 or >139 mmHg, Temperature <35 or >37.4 degrees Celsius, Respiration rate <7 or >25 R/min.
- Subject has any significant ECG abnormality.
- The subject has a positive prestudy human immunodeficiency virus-1/2 antibodies (HIV-1/2Ab), Positive Hepatitis B Surface Antigen (HepBsAg) (indicative of chronic Hepatitis B) or detectable Hepatitis C virus Ribonucleic acid (RNA) by Polymerase Chain Reaction (PCR) (indicative of active Hepatitis C - screening is generally done by Hepatitis C Antibody (HepCAb), followed by Hepatitis C virus RNA by PCR if HepCAb is positive) result at screening.
- Subject has been involved in testing an investigational drug in another clinical study within the last 4 weeks.
- Subject is in a situation or has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Centre for Clinical Pharmacology, UZ Leuven
Leuven, Vlaams-Brabant, 3000
About this study
Official title: Development of a Target Engagement Biomarker for Future PAC1 Antagonists With the Use of Intradermal Injected Maxadilan Induced Dermal Blood Flow Changes, Assessed by Laser Doppler Imaging
This will be a single center, open-label study in healthy male subjects between 18 and 45 years old to determine the dose response profiles of dermal blood flow in response to intradermal injections of maxadilan. The study will consist of 2 parts: Part I: dose and time finding and Part II: reproducibility over time.
- Conditions
- Healthy Volunteers
- Being tested
- Maxadilan, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaxadilanDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Intradermal injection of maxadilan solution Receives: Drug: Maxadilan |
| Placebo | Placebo comparator | Intradermal injection of placebo (=vehicle) solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dermal blood flow induced by intradermal injections of maxadilan, compared to baseline and placebo for different doses, time point and in terms of reproducibility over time (i.e. inter-period reproducibility).
Measured: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II)
Changes in vital signs.
as a measure of safety
Measured: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) and at 5-7 days after last studyvisit (post-study visit)
Changes in ECG.
as a measure of safety
Measured: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) and at at 5-7 days after last studyvisit (post-study visit)
Change in laboratory safety tests.
as a measure of safety
Measured: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) and at at 5-7 days after last studyvisit (post-study visit)
Change in physical examination.
as a measure of safety
Measured: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) and at at 5-7 days after last studyvisit (post-study visit)
Secondary outcomes (2)
Tolerability of intradermal injections of maxadilan in healthy male subjects. Assessed using the Numerical rating scale-11 for pain.
Assessed using the Numerical rating scale-11 for pain.
Measured: Every study visit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) and at at 5-7 days after last studyvisit (post-study visit)
Change in dermal blood flow induced by intradermal injections of maxadilan, compared to baseline and placebo in terms of reproducibility between arms (i.e. inter-arm reproducibility.
Measured: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2015
- Study completionApr 2015
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.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355756
- Sponsor's protocol ID
- CCP14-3301-PAC1
- Status last verified
- Jan 2015
- First submitted
- 15 Jan 2015
- Last updated
- 10 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Target Engagement Biomarker for Future PAC1 Antagonists With the Use of Intradermal Injected Maxadilan Induced Dermal Blood Flow Changes, Assessed by Laser Doppler Imaging
- ClinicalTrials.gov ID
- NCT02355756
- Acronym / sponsor ID
- CCP14-3301-PAC1
- Conditions
- Healthy Volunteers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 4 Feb 2015 (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.
This will be a single center, open-label study in healthy male subjects between 18 and 45 years old to determine the dose response profiles of dermal blood flow in response to intradermal injections of maxadilan. The study will consist of 2 parts: Part I: dose and time finding and Part II: reproducibility over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: MaxadilanIntradermal injection of maxadilan solution |
| Placebo | Placebo comparator | Drug: PlaceboIntradermal injection of placebo (=vehicle) solution |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject is a white male ≥18 and ≤ 45 years of age.
- Subject is a nonsmoker for at least 6 months prior to study start.
- Subject has a body mass index between 18-28 kg/m2.
- Subject is judged to be in good health on the basis of medical history, physical examination, vital signs, electrocardiogram, and routine laboratory data (including complete blood count, complete chemistry panel, prothrombin time and activated partial thromboplastin time (see Appendix C).
- Subjects must agree to practice a highly effective method of birth control during the study and for 1 week after dosing. Highly effective method of birth control includes sexual abstinence, vasectomy, or a condom in combination with hormonal birth control or intrauterine device (female partner).
Key exclusion criteria (16 listed)
- Subject has a history of any illness (including migraine) or has had/is expected to have surgery within 1 month of the start of the study which, in the investigator's opinion, might confound the results of the study.
- Subject has eczema, scleroderma, psoriasis, dermatitis, or keloids, tumors, ulcers, burns, flaps, or grafts on their forearm or other abnormality of the skin which may interfere with the study assessments.
- Subject has excessive hair growth on volar surface of the forearm.
- Subject cannot avoid excessive tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and cannot cover forearms for 24 hours prior to each treatment period.
- Subject has a history of significant (drug) allergies including adverse experiences of a serious nature related to the administration of either a marketed or investigational drug or allergic reactions related to insect bites
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 |
|---|---|---|
| Maxadilan | Drug | Active |
| Placebo | Drug | Placebo |
Primary outcome
Change in dermal blood flow induced by intradermal injections of maxadilan, compared to baseline and placebo for different doses, time point and in terms of reproducibility over time (i.e. inter-period reproducibility).
Time frame: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II)
Changes in vital signs.
Time frame: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) and at 5-7 days after last studyvisit (post-study visit)
as a measure of safety
Changes in ECG.
Time frame: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) and at at 5-7 days after last studyvisit (post-study visit)
as a measure of safety
Change in laboratory safety tests.
Time frame: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) and at at 5-7 days after last studyvisit (post-study visit)
as a measure of safety
Change in physical examination.
Time frame: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) and at at 5-7 days after last studyvisit (post-study visit)
as a measure of safety
2 secondary outcomes
Tolerability of intradermal injections of maxadilan in healthy male subjects. Assessed using the Numerical rating scale-11 for pain.
Time frame: Every study visit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) and at at 5-7 days after last studyvisit (post-study visit)
Change in dermal blood flow induced by intradermal injections of maxadilan, compared to baseline and placebo in terms of reproducibility between arms (i.e. inter-arm reproducibility.
Time frame: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II)
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 10 Jul 2015.
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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 Early Phase 1 study testing Maxadilan in people with Healthy Volunteers, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 8 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 10 Jul 2015. 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 Belgium. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in dermal blood flow induced by intradermal injections of maxadilan, compared to baseline and placebo for different doses, time point and in terms of reproducibility over time (i.e. inter-period reproducibility). (time frame: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II)). The study lists 5 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 10 Jul 2015.