Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03212131
• Date of registration: 30/06/2017
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.
• Scientific title: Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function
• Date of first enrolment: August 16, 2017
• Target sample size: 34
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03212131
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Slovakia

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female aged 18-75 years (both inclusive)

- Body mass index of 18.5-39.9 kg/sqm (both inclusive)

- Subjects with normal hepatic function or hepatic impairment (mild or moderate)

Exclusion Criteria:

- Female who is pregnant, breast-feeding or intends to become pregnant or is of
child-bearing potential and not using an adequate contraceptive method (adequate
contraceptive measure as required by local regulation or practice) for at least 16
days after the last trial product administration

- Male of reproductive age who or whose partner(s) is not using adequate contraceptive
methods (adequate contraceptive measures as required by local regulation or practice)
or male who is not willing to refrain from donating semen for at least 16 days after
last trial product administration

- Any blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma
in excess of 400 mL within the 90 days preceding screening

- Any disorder, except for conditions associated with hepatic impairment in the group of
subjects with compromised hepatic function, which in the investigator's opinion might
jeopardise subject's safety, evaluation of results, or compliance with the protocol



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Adult Growth Hormone Deficiency

Growth Hormone Disorder

Growth Hormone Deficiency in Children

Intervention(s)

Drug: Somapacitan

Primary Outcome(s)

Area under the somapacitan serum concentration time curve [Time Frame: From time 0 to 168 hours after the last dosing on Day 15]

Secondary Outcome(s)

Time to maximum serum concentration of somapacitan [Time Frame: After the last dosing on Day 15 until Day 43]

Incidence of adverse events [Time Frame: From first dosing to Day 43]

Maximum serum concentration of somapacitan [Time Frame: After the last dosing on Day 15 until Day 43]

Occurrence of anti-somapacitan antibodies [Time Frame: From Day 0 to Day 43]

Secondary ID(s)

NN8640-4298

U1111-1187-9247

2016-003911-36

Source(s) of Monetary Support

Please refer to primary and secondary sponsors