Overview
Sponsor-declared trial summary
Vascular dysfunction
To assess whether carbachol is comparable to acetylcholine for evaluating realtive and absolute forearm blood flow (FBF). FBF is evaluated by classic venous occlusion-plethysmography.
Key facts
- Sponsor
- Regionshospitalet Godstrup
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Circulatory and Respiratory Physiological Phenomena [G09], Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 2 Jun 2023 → 17 Aug 2023
- Decision date (initial)
- 2023-05-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Pharmacodynamic, Pharmacokinetic
To assess whether carbachol is comparable to acetylcholine for evaluating realtive and absolute forearm blood flow (FBF). FBF is evaluated by classic venous occlusion-plethysmography.
Conditions and MedDRA coding
Vascular dysfunction
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Healthy men or women
- Age between 18-40 years
- Fertile women has to receive contraceptive treatment
- Body mass index (BMI) between 18.5-30 kg/m2
Exclusion criteria 9
- Arterial hypertension defined as office blood pressure above 140 mmHg systolic and/or 90 mmHg diastolic
- Significant clinical signs of disease in heart, lungs, liver, kidney, endocrine organs or brain or neoplastic disease
- Clinical significant abnormalities in blood- or urine samples collected at the screening examination
- Clinical significant abnormalities in electrocardiogram (ECG) made at the screening examination
- Abuse of alcohol, defined as more than 14 units per week
- Abuse of drugs
- Pharmacological treatment, contraveptive medicine exepted
- Smoking
- Pregnancy or breast feeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Relative and absolute forearm blood flow (FBF)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Miochol®-E, 20mg, Powder and Solvent for instillation solution for intraocular use
PRD295720 · Product
- Active substance
- Acetylcholine Chloride
- Pharmaceutical form
- INTRAOCULAR INSTILLATION SOLUTION
- Route of administration
- INTRAARTERIAL USE
- Max daily dose
- 3.1 mg milligram(s)
- Max total dose
- 3.1 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- S01EB09 — ACETYLCHOLINE
- Marketing authorisation
- PL13757/0017
- MA holder
- DR. GERHARD MANN CHEM.-PHARM. FABRIK GMBH
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
MIOSTAT 0,01 % intraokulare Injektionslösung
PRD7430464 · Product
- Active substance
- Carbachol
- Pharmaceutical form
- INTRAOCULAR INSTILLATION SOLUTION
- Route of administration
- INTRAARTERIAL USE
- Max daily dose
- 67 µg microgram(s)
- Max total dose
- 67 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- S01EB02 — CARBACHOL
- Marketing authorisation
- BE138537
- MA holder
- ALCON NV
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Regionshospitalet Godstrup
- Sponsor organisation
- Regionshospitalet Godstrup
- Address
- Hospitalsparken 15
- City
- Herning
- Postcode
- 7400
- Country
- Denmark
Scientific contact point
- Organisation
- Regionshospitalet Godstrup
- Contact name
- Didde Kidmose Kristensen, Universitetsklinik i Nyresygdomme og Blodtryksforhøjelse
Public contact point
- Organisation
- Regionshospitalet Godstrup
- Contact name
- Didde Kidmose Kristensen, Universitetsklinik i Nyresygdomme og Blodtryksforhøjelse
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus University ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 1 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2023-06-02 | 2023-08-17 | 2023-06-02 | 2023-08-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Resumé af resultater 2023-503908-87-00 SUM-41349
|
2024-08-16T18:42:45 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Resumé for lægmænd 2023-503908-87-00 | 2024-08-16T18:43:36 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Resume for lgmnd af resultaterne af det kliniske forsg 2023-503908-87-00 | 1 |
| Summary of results (for publication) | Resume af resultater PACCA 2023-503908-87-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-23 | Denmark | Acceptable 2023-05-25
|
2023-05-25 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-05-26 | Denmark | Acceptable 2023-05-25
|
2023-05-26 |