Growth Hormone DisorderPhase 1NCT01034202
Dose Study in Healthy Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Compared to Norditropin® SimpleXx®
A Phase 1 study testing NNC126-0083 and Norditropin® SimpleXx® in people with Growth Hormone Disorder and Healthy, run by Novo Nordisk A/S at 1 site in Denmark.
Trial summary
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NNC126-0083 compared to Norditropin® SimpleXx® and placebo in healthy volunteers Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Growth Hormone Disorder, Healthy
- What is being tested?
- NNC126-0083 and Norditropin® SimpleXx®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2007to Jan 2008
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, non-smoking male subjects
- Body Mass Index (BMI) between 19.0 and 28.0 kg/m2, both inclusive
- Body weight max. 100 kg
Who cannot join
- A history or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major diseases
- Carrier of Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies
- Positive result of test for HIV (Human Immunodeficiency Virus) antibodies
- Any clinically significant abnormal haematology or biochemistry screening tests, as judged by the physician
- Clinically significant abnormal ECG (ElectroCardioGram) at screening as evaluated by the physician
- A significant history of alcoholism or drug/chemical abuse, or who has a positive result in the urine drug/alcohol screen, or who consumes more than 28 units of alcohol per week (one unit of alcohol equals about 250 ml of beer or lager, 1 glass of wine, or 20 ml of spirits)
Show all 9Show fewer
- Habitual smoking, i.e daily smoking or more than 7 cigarettes/week
- Mental incapacity or language barriers which preclude adequate understanding or cooperation, who are unwilling to participate in the trial, or who in the opinion of their general practitioner or the Investigator should not participate in the trial
- Surgery or trauma with significant blood loss within the last 2 months prior to dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double Blind, Placebo-controlled, Single Dose, Dose-escalating Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin® SimpleXx® in Healthy Male Subjects
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NNC126-0083 compared to Norditropin® SimpleXx® and placebo in healthy volunteers
- Conditions
- Growth Hormone Disorder, Healthy
- Being tested
- NNC126-0083, Norditropin® SimpleXx®, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC126-0083Drug
One of five dose levels administered subcutaneously (under the skin)
Norditropin® SimpleXx®Drug
One of two dose levels, followed by NNC126-0083, administered subcutaneously (under the skin)
placeboDrug
Placebo comparator
NNC126-0083Drug
One of three dose levels administered subcutaneously (under the skin)
Norditropin® SimpleXx®Drug
One of two dose levels, followed by placebo, administered subcutaneously (under the skin)
| Study group | Role | What they receive |
|---|---|---|
| Norditropin® SimpleXx® 0.02 mg/kg + NNC126-0083 | Experimental | Not described Receives: Drug: NNC126-0083; Drug: Norditropin® SimpleXx® |
| Norditropin® SimpleXx® 0.04 mg/kg + NNC126-0083 | Experimental | Not described Receives: Drug: NNC126-0083; Drug: Norditropin® SimpleXx® |
| Norditropin® SimpleXx® 0.02 mg/kg + placebo | Placebo comparator | Not described Receives: Drug: placebo; Drug: Norditropin® SimpleXx® |
| Norditropin® SimpleXx® 0.04 mg/kg + placebo | Placebo comparator | Not described Receives: Drug: placebo; Drug: Norditropin® SimpleXx® |
| NNC126-0083 | Experimental | Not described Receives: Drug: NNC126-0083 |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Measured: after administration of a single dose of NNC126-0083
Secondary outcomes (3)
Area under the curve (AUC) (0-168h) after a single dose of NNC 126-0083
Measured: 0-168 hours after trial drug administration
Number of injection site reactions
Measured: after administration of a single dose of NNC126-0083 and after single dose of Norditropin® SimpleXx®
IGF-I (Insulin-like Growth Factor I) levels
Measured: after ascending single doses of NNC126-0083 and a single dose of Norditropin® SimpleXx®
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startAug 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 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
- NCT01034202
- Sponsor's protocol ID
- NN8630-1822
- Other IDs
- 2007-001255-19
- Status last verified
- Feb 2017
- First submitted
- 16 Dec 2009
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Rasmussen MH, Bysted BV, Anderson TW, Klitgaard T, Madsen J. Pegylated long-acting human growth hormone is well-tolerated in healthy subjects and possesses a potential once-weekly pharmacokinetic and pharmacodynamic treatment profile. J Clin Endocrinol Metab. 2010 Jul;95(7):3411-7. doi: 10.1210/jc.2009-2813. Epub 2010 Apr 28.
PubMed 20427496
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo-controlled, Single Dose, Dose-escalating Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin® SimpleXx® in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01034202
- Acronym / sponsor ID
- NN8630-1822
- Conditions
- Growth Hormone Disorder, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 17 Dec 2009 (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, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NNC126-0083 compared to Norditropin® SimpleXx® and placebo in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Norditropin® SimpleXx® 0.02 mg/kg + NNC126-0083 | Experimental | Drug: NNC126-0083, Drug: Norditropin® SimpleXx® |
| Norditropin® SimpleXx® 0.04 mg/kg + NNC126-0083 | Experimental | Drug: NNC126-0083, Drug: Norditropin® SimpleXx® |
| Norditropin® SimpleXx® 0.02 mg/kg + placebo | Placebo comparator | Drug: placebo, Drug: Norditropin® SimpleXx® |
| Norditropin® SimpleXx® 0.04 mg/kg + placebo | Placebo comparator | Drug: placebo, Drug: Norditropin® SimpleXx® |
| NNC126-0083 | Experimental | Drug: NNC126-0083 |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy, non-smoking male subjects
- Body Mass Index (BMI) between 19.0 and 28.0 kg/m2, both inclusive
- Body weight max. 100 kg
Key exclusion criteria (9 listed)
- A history or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major diseases
- Carrier of Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies
- Positive result of test for HIV (Human Immunodeficiency Virus) antibodies
- Any clinically significant abnormal haematology or biochemistry screening tests, as judged by the physician
- Clinically significant abnormal ECG (ElectroCardioGram) at screening as evaluated by the physician
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 |
|---|---|---|
| NNC126-0083One of five dose levels administered subcutaneously (under the skin) | Drug | Norditropin® SimpleXx® 0.02 mg/kg + NNC126-0083, Norditropin® SimpleXx® 0.04 mg/kg + NNC126-0083 |
| Norditropin® SimpleXx®One of two dose levels, followed by NNC126-0083, administered subcutaneously (under the skin) | Drug | Norditropin® SimpleXx® 0.02 mg/kg + NNC126-0083, Norditropin® SimpleXx® 0.04 mg/kg + NNC126-0083 |
| placeboPlacebo comparator | Drug | Norditropin® SimpleXx® 0.02 mg/kg + placebo, Norditropin® SimpleXx® 0.04 mg/kg + placebo, Placebo |
| NNC126-0083One of three dose levels administered subcutaneously (under the skin) | Drug | NNC126-0083 |
| Norditropin® SimpleXx®One of two dose levels, followed by placebo, administered subcutaneously (under the skin) | Drug | Norditropin® SimpleXx® 0.02 mg/kg + placebo, Norditropin® SimpleXx® 0.04 mg/kg + placebo |
Primary outcome
Number of adverse events
Time frame: after administration of a single dose of NNC126-0083
3 secondary outcomes
Area under the curve (AUC) (0-168h) after a single dose of NNC 126-0083
Time frame: 0-168 hours after trial drug administration
Number of injection site reactions
Time frame: after administration of a single dose of NNC126-0083 and after single dose of Norditropin® SimpleXx®
IGF-I (Insulin-like Growth Factor I) levels
Time frame: after ascending single doses of NNC126-0083 and a single dose of Norditropin® SimpleXx®
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 9 Feb 2017.
- Results publication: PubMed 20427496Rasmussen MH, Bysted BV, Anderson TW, Klitgaard T, Madsen J. Pegylated long-acting human growth hormone is well-tolerated in healthy subjects and possesses a potential once-weekly pharmacokinetic and pharmacodynamic treatment profile. J Clin Endocrinol Metab. 2010 Jul;95(7):3411-7. doi: 10.1210/jc.2009-2813. Epub 2010 Apr 28.
- 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 NNC126-0083 and Norditropin® SimpleXx® in people with Growth Hormone Disorder and Healthy, run by Novo Nordisk A/S at 1 site in Denmark.
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 3 inclusion and 9 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 9 Feb 2017. 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 Denmark. 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?
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?
Number of adverse events (time frame: after administration of a single dose of NNC126-0083). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01034202, which also lists 1 linked publication.
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 9 Feb 2017.