- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02355756
Biomarker Development for Future PAC1 Antagonists With Maxadilan
9 lipca 2015 zaktualizowane przez: Universitaire Ziekenhuizen KU Leuven
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.
Przegląd badań
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
20
Faza
- Wczesna faza 1
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgia, 3000
- Centre for Clinical Pharmacology, UZ Leuven
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 45 lat (Dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Męski
Opis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: Active
Intradermal injection of maxadilan solution
|
|
Komparator placebo: Placebo
Intradermal injection of placebo (=vehicle) solution
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
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).
Ramy czasowe: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II)
|
Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II)
|
|
Changes in vital signs.
Ramy czasowe: 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
|
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.
Ramy czasowe: 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
|
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.
Ramy czasowe: 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
|
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.
Ramy czasowe: 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
|
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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Tolerability of intradermal injections of maxadilan in healthy male subjects. Assessed using the Numerical rating scale-11 for pain.
Ramy czasowe: 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)
|
Assessed using the Numerical rating scale-11 for pain.
|
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.
Ramy czasowe: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II)
|
Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II)
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 stycznia 2015
Zakończenie podstawowe (Rzeczywisty)
1 kwietnia 2015
Ukończenie studiów (Rzeczywisty)
1 kwietnia 2015
Daty rejestracji na studia
Pierwszy przesłany
15 stycznia 2015
Pierwszy przesłany, który spełnia kryteria kontroli jakości
30 stycznia 2015
Pierwszy wysłany (Oszacować)
4 lutego 2015
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
10 lipca 2015
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
9 lipca 2015
Ostatnia weryfikacja
1 stycznia 2015
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CCP14-3301-PAC1
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Placebo
-
SamA Pharmaceutical Co., LtdNieznanyOstre zapalenie oskrzeli | Ostra infekcja górnych dróg oddechowychRepublika Korei
-
National Institute on Drug Abuse (NIDA)ZakończonyUżywanie konopi indyjskichStany Zjednoczone
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyZakończonyMężczyźni z cukrzycą typu II (T2DM)Niemcy
-
Heptares Therapeutics LimitedZakończonyFarmakokinetyka | Problemy z bezpieczeństwemZjednoczone Królestwo
-
West Penn Allegheny Health SystemZakończonyAstma | Alergiczny nieżyt nosaStany Zjednoczone
-
Soroka University Medical CenterZakończony
-
Regado Biosciences, Inc.ZakończonyZdrowy ochotnikStany Zjednoczone
-
ItalfarmacoZakończonyDystrofia mięśniowa BeckeraHolandia, Włochy
-
Longeveron Inc.ZakończonyZespół niedorozwoju lewego sercaStany Zjednoczone