A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03905850
• Date of registration: 03/04/2019
• Prospective Registration: No
• Primary sponsor: Novo Nordisk A/S
• Public title: A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects
• Scientific title: A Randomised, Double-blind, Single Dose, Three Period, Complete Cross Over Trial in Healthy Subjects Investigating the Pharmacokinetics of Subcutaneous Injections of Somapacitan 5 mg/1.5 mL and 10 mg/1.5 mL
• Date of first enrolment: March 29, 2019
• Target sample size: 33
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03905850
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Clinical Reporting Anchor and Disclosure (1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female, aged 18-45 years (both inclusive) at the time of signing informed
consent.

- Body mass index (BMI) between 18.5 and 24.9 kg/m^2 (both inclusive).

- Considered to be generally healthy based on the medical history, physical examination,
and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests
performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

- Participation in any clinical trial of an approved or non-approved investigational
medicinal product within 45 days or 5 times the half-life of the previous
investigational medicinal product, whichever is longer, before screening.

- Body weight above 100.0 kg

- Subject with any known history of growth hormone deficiency as declared by the
subject.

- Subject who is non-naïve to growth hormone treatment as declared by the subject.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Healthy Volunteers

Intervention(s)

Drug: somapacitan

Primary Outcome(s)

Area under the somapacitan serum concentration time curve from time 0 to the time of the last quantifiable concentration after dosing [Time Frame: 0 to 504 hours after trial product administration]

Maximum serum concentration of somapacitan [Time Frame: 0 to 504 hours after trial product administration]

Secondary Outcome(s)

Terminal half-life of somapacitan [Time Frame: 0 to 504 hours after trial product administration]

Area under the somapacitan serum concentration time curve from time 0 to infinity [Time Frame: 0 to 504 hours after trial product administration]

Area under the insulin-like growth factor I (IGF-I) serum concentration time curve from time 0 to 168 hours after dosing [Time Frame: 0 to 168 hours after trial product administration]

Area under the somapacitan serum concentration time curve from time 0 to 168 hours after dosing [Time Frame: 0 to 168 hours after trial product administration]

Maximum serum concentration of IGF-I after dosing [Time Frame: 0 to 504 hours after trial product administration]

Time to maximum serum concentration of IGF-I after dosing [Time Frame: 0 to 504 hours after trial product administration]

Time to maximum serum concentration of somapacitan [Time Frame: 0 to 504 hours after trial product administration]

Secondary ID(s)

U1111-1220-5197

2018-003670-27

NN8640-4491

Source(s) of Monetary Support

Please refer to primary and secondary sponsors