Healthy Clinical Trial
Official title:
First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects
Verified date | December 2020 |
Source | Novo Nordisk A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial is conducted in Europe. The aim of this trial is to assess safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0195-0092 (somapacitan) compared to placebo in healthy male subjects.
Status | Completed |
Enrollment | 105 |
Est. completion date | March 18, 2013 |
Est. primary completion date | March 18, 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 20 Years to 45 Years |
Eligibility | Inclusion Criteria: - Healthy, non-smoking male subjects - BMI (body mass index) between 18.0 and 28.0 kg/m^2, both incl. - Body weight 50 to 100 kg, both incl. Exclusion Criteria: - Strenuous exercise within 4 days prior to dosing - Receipt of any investigational medicinal product within 3 months prior to randomisation |
Country | Name | City | State |
---|---|---|---|
Germany | Novo Nordisk Investigational Site | Neuss |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
Germany,
Juul Kildemoes R, Højby Rasmussen M, Agersø H, Overgaard RV. Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan. J Clin Endocrinol Metab. 2020 Dec 12. pii: dgaa775. doi: 10.1210/clinem/dgaa775. [Epub ahead of print] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of adverse events (Single Dose) | From first administration of trial product and up until day 40 | ||
Primary | Incidence of adverse events (Multiple Dose) | From first administration of trial product and up until day 49 | ||
Secondary | Area under the NNC0195-0092 (somapacitan) serum concentration-time curve | From 0 to 168 hours | ||
Secondary | Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only) | From 0-240 hours | ||
Secondary | Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only) | up to day 40 | ||
Secondary | Maximum serum concentration (Cmax) for NNC0195-0092 (somapacitan) | up to day 40 | ||
Secondary | Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve | From 0-168 hours | ||
Secondary | Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve (SD part only) | From 0-240 hours | ||
Secondary | Maximum serum concentration (Cmax) for IGF-I | up to day 40 | ||
Secondary | Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve | From 0-168 hours | ||
Secondary | Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve (SD part only) | From 0-240 hours | ||
Secondary | Maximum serum concentration (Cmax) for IGFBP-3 | up to day 40 | ||
Secondary | Number of injection site reactions | From first administration of trial product and up until day 40 (SD part) | ||
Secondary | Number of injection site reactions | From first administration of trial product and up until day 49 (MD part) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |