Healthy VolunteersEarly Phase 1NCT05178550
A Study in Healthy Participants Investigating Biomarkers After Exposure to Heparin When Heparin is Administered in the Fasted State or After a High-fat Meal. Heparin, a Registered Drug, is an Anticoagulant (Blood Thinner) That Prevents the Formation of Blood Clots.
A Early Phase 1 study testing Heparin in people with Healthy Volunteers, run by Novo Nordisk A/S at 1 site in Netherlands.
Trial summary
In this study biomarkers in the blood after exposure to heparin in the fasted state or after a high-fat meal will be investigated. Heparin will be administered as an intravenous (iv) injection (injection directly in a blood vessel). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Dec 2021to 17 Jan 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subject
- Male or female
- 18 to 65 years, inclusive, at the time of signing informed consent
- Body mass index:18.0 kg/m ^2 to 29.9 kg/m^2, inclusive, at the time of signing informed consent
- Body weight greater than or equal to 50 kg at the time of signing informed consent
Who cannot join
- Using tobacco products within 60 days prior to the first drug administration.
- Any kind of coagulation disorder or any first degree family members with major bleeding tendency.
- History of anemia, thrombocytopenia, HIT, other blood disorders, or any clinically relevant bleeding (epistaxis).
- Exposure to heparin (unfractionated heparin or low molecular weight heparin) within 100 days prior to the first dose of heparin.
- Participation in any clinical study of an approved or non-approved investigational medicinal product within 30 days (or 5 half-lives of the investigational medicinal product, whichever is greater) before screening. If the half-life of the investigational medicinal product is unknown, subjects participating in a clinical trial in the 6 months prior to (the first) treatment administration will be excluded.
- Any kind of coagulation disorder or any first degree family members with major bleeding tendency.
- Unwillingness to consume the entire high-fat standardized meal (e.g. vegetarians, vegans and subjects who follow special diets).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Single Center, Crossover Study in Healthy Participants to Assess Lipoprotein Lipase Activity and Levels, and Triglyceride Levels After Heparin Exposure, in Both Fasted and Postprandial State
In this study biomarkers in the blood after exposure to heparin in the fasted state or after a high-fat meal will be investigated. Heparin will be administered as an intravenous (iv) injection (injection directly in a blood vessel). In this study, the effects of administration of heparin will be compared with the effects of administration of normal saline which will also be administered as an iv injection.
- Conditions
- Healthy Volunteers
- Being tested
- Heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
intravenous [iv] injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (low dose-high dose) | Experimental | Participants receive 25 IU/kg heparin on days 1 and 2, and 50 IU/kg Heparin on days 4 and 5 Receives: Drug: Heparin |
| Group 2 (high dose-low dose) | Experimental | Participants receive 50 IU/kg heparin on days 1 and 2, and 25 IU/kg Heparin on days 4 and 5 Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Lipoprotein Lipase (LPL) levels before and after heparin exposure both in fasted and postprandial state
ng/ml
Measured: day -1 to day 6
Change from baseline in LPL activity before and after heparin exposure both in fasted and postprandial state
µmol/l/min
Measured: day -1 to day 6
Change from baseline in Triglycerides (TG) levels before and after heparin exposure both in fasted and postprandial state
mmol/L
Measured: day -1 to day 6
Secondary outcomes (6)
Change from baseline in apolipoprotein CII (APOCII) levels before and after heparin exposure both in fasted and postprandial state
mg/L
Measured: day -1 to day 6
Change from baseline in APOCIII levels before and after heparin exposure both in fasted and postprandial state
mg/dl
Measured: day -1 to day 6
Change from baseline in total cholesterol levels before and after heparin exposure both in fasted and postprandial state
mmol/L
Measured: day -1 to day 6
Change from baseline in Free fatty acids (FFA) levels before and after heparin exposure both in fasted and postprandial state
mmol/L
Measured: day -1 to day 6
Change from baseline in Lipoprotein profiling (very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL), high-density lipoprotein (HDL) before and after heparin exposure both in fasted and postprandial state
mmol.L-1
Measured: day -1 to day 6
Change from baseline in adverse events (AEs) before and after heparin exposure both in fasted and postprandial state
Number of events
Measured: day -1 to day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start17 Dec 2021
- Primary completion11 Jan 2022
- Study completion17 Jan 2022
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 Novo Nordisk A/SThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178550
- Sponsor's protocol ID
- NN6633-4955
- Other IDs
- 2021-005899-18, U1111-1270-0957
- Status last verified
- May 2023
- First submitted
- 14 Dec 2021
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single Center, Crossover Study in Healthy Participants to Assess Lipoprotein Lipase Activity and Levels, and Triglyceride Levels After Heparin Exposure, in Both Fasted and Postprandial State
- ClinicalTrials.gov ID
- NCT05178550
- Acronym / sponsor ID
- NN6633-4955
- Conditions
- Healthy Volunteers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 17 Jan 2022 (actual)
- First posted
- 5 Jan 2022 (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.
In this study biomarkers in the blood after exposure to heparin in the fasted state or after a high-fat meal will be investigated. Heparin will be administered as an intravenous (iv) injection (injection directly in a blood vessel). In this study, the effects of administration of heparin will be compared with the effects of administration of normal saline which will also be administered as an iv injection.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (low dose-high dose) | Experimental | Drug: HeparinParticipants receive 25 IU/kg heparin on days 1 and 2, and 50 IU/kg Heparin on days 4 and 5 |
| Group 2 (high dose-low dose) | Experimental | Drug: HeparinParticipants receive 50 IU/kg heparin on days 1 and 2, and 25 IU/kg Heparin on days 4 and 5 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy subject
- Male or female
- 18 to 65 years, inclusive, at the time of signing informed consent
- Body mass index:18.0 kg/m ^2 to 29.9 kg/m^2, inclusive, at the time of signing informed consent
- Body weight greater than or equal to 50 kg at the time of signing informed consent
Key exclusion criteria (7 listed)
- Using tobacco products within 60 days prior to the first drug administration.
- Any kind of coagulation disorder or any first degree family members with major bleeding tendency.
- History of anemia, thrombocytopenia, HIT, other blood disorders, or any clinically relevant bleeding (epistaxis).
- Exposure to heparin (unfractionated heparin or low molecular weight heparin) within 100 days prior to the first dose of heparin.
- Participation in any clinical study of an approved or non-approved investigational medicinal product within 30 days (or 5 half-lives of the investigational medicinal product, whichever is greater) before screening. If the half-life of the investigational medicinal product is unknown, subjects participating in a clinical trial in the 6 months prior to (the first) treatment administration will be excluded.
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 |
|---|---|---|
| Heparinintravenous [iv] injection | Drug | Group 1 (low dose-high dose), Group 2 (high dose-low dose) |
Primary outcome
Change from baseline in Lipoprotein Lipase (LPL) levels before and after heparin exposure both in fasted and postprandial state
Time frame: day -1 to day 6
ng/ml
Change from baseline in LPL activity before and after heparin exposure both in fasted and postprandial state
Time frame: day -1 to day 6
µmol/l/min
Change from baseline in Triglycerides (TG) levels before and after heparin exposure both in fasted and postprandial state
Time frame: day -1 to day 6
mmol/L
6 secondary outcomes
Change from baseline in apolipoprotein CII (APOCII) levels before and after heparin exposure both in fasted and postprandial state
Time frame: day -1 to day 6
Change from baseline in APOCIII levels before and after heparin exposure both in fasted and postprandial state
Time frame: day -1 to day 6
Change from baseline in total cholesterol levels before and after heparin exposure both in fasted and postprandial state
Time frame: day -1 to day 6
Change from baseline in Free fatty acids (FFA) levels before and after heparin exposure both in fasted and postprandial state
Time frame: day -1 to day 6
Change from baseline in Lipoprotein profiling (very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL), high-density lipoprotein (HDL) before and after heparin exposure both in fasted and postprandial state
Time frame: day -1 to day 6
Change from baseline in adverse events (AEs) before and after heparin exposure both in fasted and postprandial state
Time frame: day -1 to day 6
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 22 May 2023.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
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 Heparin in people with Healthy Volunteers, run by Novo Nordisk A/S at 1 site in Netherlands.
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 5 inclusion and 7 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 22 May 2023. 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 Netherlands. 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. 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 from baseline in Lipoprotein Lipase (LPL) levels before and after heparin exposure both in fasted and postprandial state (time frame: day -1 to day 6). The study lists 3 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 22 May 2023.