Genetic DisorderPhase 1NCT01401244
Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers
A Phase 1 study testing somatropin in people with Genetic Disorder and Prader-Willi Syndrome, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
This trial is conducted in United States of America (USA). The aim of this trial is to examine the bioequivalence of Norditropin® versus Genotropin® in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Genetic Disorder, Prader-Willi Syndrome, Growth Disorder
- What is being tested?
- somatropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2011to 27 Sep 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index (BMI) 18.0-27.0 kg/m^2 (both inclusive)
- Considered generally healthy upon completion of medical history, physical examination, vital signs, screening laboratory results, and electrocardiogram (ECG), as judged by the Investigator (trial physician)
Who cannot join
- The receipt of any investigational medicinal product within 1 month prior to this trial
- Current or previous treatment with growth hormone or IGF-I (insulin-like growth factor-I)
- Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) for the duration of the trial
- Known presence or history of malignancy
- Diabetes mellitus
- Use of pharmacologic doses of glucocorticoids
- Use of anabolic steroids
- History of drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Investigational Site
Evansville, Indiana, 47710
About this study
Official title: A Trial to Examine the Bioequivalence of Norditropin® Versus Genotropin® in Healthy Adult Volunteers
This trial is conducted in United States of America (USA). The aim of this trial is to examine the bioequivalence of Norditropin® versus Genotropin® in healthy adult volunteers.
- Conditions
- Genetic Disorder, Prader-Willi Syndrome, Growth Disorder, Idiopathic Short Stature, Healthy
- Being tested
- somatropin
- Medical subject headings
- Genetic Diseases, Inborn, Prader-Willi Syndrome, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
A single dose 4.0 mg administered subcutaneously (under the skin) via Norditropin® FlexPro® pen
somatropinDrug
A single dose 4.0 mg administered subcutaneously (under the skin) via Genotropin® Pen 12
| Study group | Role | What they receive |
|---|---|---|
| Norditropin® | Experimental | Not described Receives: Drug: somatropin |
| Genotropin® | Active comparator | Not described Receives: Drug: somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum hGH (human growth hormone) concentration-time curve
Measured: from 0 to the time of the last quantifiable concentration over a 24-hour sampling period
Maximum observed serum hGH concentration
Measured: over a 24-hour sampling period
Secondary outcomes (8)
Area under the effect (IGF-I) curve
Measured: from time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period
Maximum IGF-I effect (Emax)
Measured: over a 96-hour sampling period
The frequency of adverse events (AE)
Measured: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
The frequency of injection site reaction
Measured: from the time of injection of the trial product (day 1 and 13, respectively) to follow-up during the two dosing periods (day 5 and 17, respectively)
Abnormal hematology laboratory parameters
Measured: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
Abnormal biochemistry laboratory parameters
Measured: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
Abnormal findings in physical examinations
Measured: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
Vital signs
Measured: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study start14 Jul 2011
- Primary completion27 Sep 2011
- Study completion27 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic 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
- None (open label)
- Enrolment
- 30 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
- NCT01401244
- Sponsor's protocol ID
- GH-3939
- Other IDs
- U1111-1121-3640
- Status last verified
- Feb 2017
- First submitted
- 20 Jul 2011
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Examine the Bioequivalence of Norditropin® Versus Genotropin® in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01401244
- Acronym / sponsor ID
- GH-3939
- Conditions
- Genetic Disorder, Prader-Willi Syndrome, Growth Disorder, Idiopathic Short Stature, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2011 (actual)
- Primary completion
- 27 Sep 2011 (actual)
- Study completion
- 27 Sep 2011 (actual)
- First posted
- 25 Jul 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 United States of America (USA). The aim of this trial is to examine the bioequivalence of Norditropin® versus Genotropin® in healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norditropin® | Experimental | Drug: somatropin |
| Genotropin® | Active comparator | Drug: somatropin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) 18.0-27.0 kg/m^2 (both inclusive)
- Considered generally healthy upon completion of medical history, physical examination, vital signs, screening laboratory results, and electrocardiogram (ECG), as judged by the Investigator (trial physician)
Key exclusion criteria (8 listed)
- The receipt of any investigational medicinal product within 1 month prior to this trial
- Current or previous treatment with growth hormone or IGF-I (insulin-like growth factor-I)
- Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) for the duration of the trial
- Known presence or history of malignancy
- Diabetes mellitus
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 |
|---|---|---|
| somatropinA single dose 4.0 mg administered subcutaneously (under the skin) via Norditropin® FlexPro® pen | Drug | Norditropin® |
| somatropinA single dose 4.0 mg administered subcutaneously (under the skin) via Genotropin® Pen 12 | Drug | Genotropin® |
Primary outcome
Area under the serum hGH (human growth hormone) concentration-time curve
Time frame: from 0 to the time of the last quantifiable concentration over a 24-hour sampling period
Maximum observed serum hGH concentration
Time frame: over a 24-hour sampling period
8 secondary outcomes
Area under the effect (IGF-I) curve
Time frame: from time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period
Maximum IGF-I effect (Emax)
Time frame: over a 96-hour sampling period
The frequency of adverse events (AE)
Time frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
The frequency of injection site reaction
Time frame: from the time of injection of the trial product (day 1 and 13, respectively) to follow-up during the two dosing periods (day 5 and 17, respectively)
Abnormal hematology laboratory parameters
Time frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
Abnormal biochemistry laboratory parameters
Time frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
Abnormal findings in physical examinations
Time frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
Vital signs
Time frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
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 24 Feb 2017.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Genetic Disorder
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
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 somatropin in people with Genetic Disorder and Prader-Willi Syndrome, run by Novo Nordisk A/S at 1 site in United States.
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 8 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 24 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 United States. 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?
Area under the serum hGH (human growth hormone) concentration-time curve (time frame: from 0 to the time of the last quantifiable concentration over a 24-hour sampling period). The study lists 2 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 24 Feb 2017.