Congenital Bleeding DisorderPhase 1NCT01272206
Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021 in Healthy Male Subjects
A Phase 1 study testing NNC 0128-0000-2011 and NNC 0128-0000-2021 in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 1 site in United Kingdom.
Trial summary
This trial is conducted in Europe. The aim of this trial is to investigate the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of NNC 0128-0000-2011 compared to NNC 0128-0000-2021 when given for the first time to healthy human subjects. Read more about this study
- Who is it for?
- Ages 18 to 49 years, men only
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- What is being tested?
- NNC 0128-0000-2011 and NNC 0128-0000-2021
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2011to Mar 2011
- 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 49 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Body weight between 50.0 and 100.0 kg, both inclusive
- Body mass index (BMI) between 18.0 and 28.0 kg/m2, both inclusive
Who cannot join
- Known or suspected hypersensitivity to trial product or related products, such as activated recombinant factor VII
- Any clinical sign or known history of atherosclerosis or thromboembolic events
- Renal dysfunction
- A subject considered at high risk of thromboembolic events
- Overt bleeding, including from gastrointestinal tract
- Hepatitis B or C infection
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- Human immunodeficiency virus (HIV) infection
- Positive test for drugs of abuse or alcohol as well as a history of alcohol or drug abuse within the past 12 months
- Smoking within 3 months prior to trial start
- Unable to abstain from alcohol consumption during visits of trial product administration, visit 2 (0-28 days after screening) and visit 3 (2-4 weeks after visit 2)
- Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator (trial physician)
- Excessive consumption of a diet deviating from a normal diet
- Blood donation within the last three months prior to screening
- The receipt of any investigational product within 30 days of trial product administration
- Participation in any other trial investigating a procoagulant within the last six months prior to screening
- Strenuous exercise within four days prior trial start
- Suffers from a life threatening disease
- Males who are sexually active and not surgically sterilised, who or whose partner are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practise).
- Subjects at increased cardiovascular risk, including a strong family history of cardiovascular disease
- Subjects with high fasting cholesterol at trial start
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Randomised, Double-blind, Single Dose, Cross-over Trial Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021, Following Intravenous Administration in Healthy Male Subjects
This trial is conducted in Europe. The aim of this trial is to investigate the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of NNC 0128-0000-2011 compared to NNC 0128-0000-2021 when given for the first time to healthy human subjects.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Being tested
- NNC 0128-0000-2011, NNC 0128-0000-2021
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC 0128-0000-2011Drug
Administered as one single i.v. (intravenous) injection, 100 mcg/kg
NNC 0128-0000-2021Drug
Administered as one single i.v. (intravenous) injection, 100 mcg/kg
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: NNC 0128-0000-2011 |
| B | Experimental | Not described Receives: Drug: NNC 0128-0000-2021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events (AEs)
Measured: from first trial product administration until maximally 10 weeks after last trial product administration
Secondary outcomes (1)
Neutralising antibodies against FVII and/or N7-GP
Measured: from first trial product administration until maximally 10 weeks after last trial product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Bleeding DisorderStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272206
- Sponsor's protocol ID
- NN7128-3729
- Other IDs
- 2010-021286-67, U1111-1118-0208
- Status last verified
- Aug 2014
- First submitted
- 6 Jan 2011
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Randomised, Double-blind, Single Dose, Cross-over Trial Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021, Following Intravenous Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01272206
- Acronym / sponsor ID
- NN7128-3729
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 7 Jan 2011 (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 trial is conducted in Europe. The aim of this trial is to investigate the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of NNC 0128-0000-2011 compared to NNC 0128-0000-2021 when given for the first time to healthy human subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: NNC 0128-0000-2011 |
| B | Experimental | Drug: NNC 0128-0000-2021 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body weight between 50.0 and 100.0 kg, both inclusive
- Body mass index (BMI) between 18.0 and 28.0 kg/m2, both inclusive
Key exclusion criteria (20 listed)
- Known or suspected hypersensitivity to trial product or related products, such as activated recombinant factor VII
- Any clinical sign or known history of atherosclerosis or thromboembolic events
- Renal dysfunction
- A subject considered at high risk of thromboembolic events
- Overt bleeding, including from gastrointestinal tract
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 |
|---|---|---|
| NNC 0128-0000-2011Administered as one single i.v. (intravenous) injection, 100 mcg/kg | Drug | A |
| NNC 0128-0000-2021Administered as one single i.v. (intravenous) injection, 100 mcg/kg | Drug | B |
Primary outcome
Frequency of adverse events (AEs)
Time frame: from first trial product administration until maximally 10 weeks after last trial product administration
1 secondary outcome
Neutralising antibodies against FVII and/or N7-GP
Time frame: from first trial product administration until maximally 10 weeks after last trial product administration
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 20 Aug 2014.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) 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 Phase 1 study testing NNC 0128-0000-2011 and NNC 0128-0000-2021 in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 1 site in United Kingdom.
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 2 inclusion and 20 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 20 Aug 2014. 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 United Kingdom. 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?
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?
Frequency of adverse events (AEs) (time frame: from first trial product administration until maximally 10 weeks after last trial product administration). 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 20 Aug 2014.