First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01514500
• Date of registration: 13/01/2012
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects
• Scientific title: First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects
• Date of first enrolment: January 16, 2012
• Target sample size: 105
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01514500
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Adult Growth Hormone Deficiency

Growth Hormone Disorder

Growth Hormone Deficiency in Children

Healthy

Intervention(s)

Drug: somapacitan

Drug: placebo (somapacitan)

Primary Outcome(s)

Incidence of adverse events (Multiple Dose) [Time Frame: From first administration of trial product and up until day 49]

Incidence of adverse events (Single Dose) [Time Frame: From first administration of trial product and up until day 40]

Secondary Outcome(s)

Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve [Time Frame: From 0-168 hours]

Maximum serum concentration (Cmax) for IGFBP-3 [Time Frame: up to day 40]

Maximum serum concentration (Cmax) for NNC0195-0092 (somapacitan) [Time Frame: up to day 40]

Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve (SD part only) [Time Frame: From 0-240 hours]

Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve (SD part only) [Time Frame: From 0-240 hours]

Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only) [Time Frame: From 0-240 hours]

Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only) [Time Frame: up to day 40]

Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve [Time Frame: From 0-168 hours]

Number of injection site reactions [Time Frame: From first administration of trial product and up until day 40 (SD part)]

Number of injection site reactions [Time Frame: From first administration of trial product and up until day 49 (MD part)]

Area under the NNC0195-0092 (somapacitan) serum concentration-time curve [Time Frame: From 0 to 168 hours]

Maximum serum concentration (Cmax) for IGF-I [Time Frame: up to day 40]

Secondary ID(s)

NN8640-3915

U1111-1119-0539

2011-000146-38

Source(s) of Monetary Support

Please refer to primary and secondary sponsors