CompletedNCT02962440Updated Jun 7, 2017

A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects

A Phase 1 interventional study of somapacitan in Healthy, sponsored by Novo Nordisk A/S. Completed at 1 site in Netherlands. Open to male participants aged 45 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-07.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 7
Allocation: Not applicable
Ages: 45 Years to 64 Years
Sex: Male

Study summary

This trial is conducted in Europe. The aim of the trial is to investigate the absorption, metabolism and excretion of somapacitan after single subcutaneous dosing in healthy male subjects.

Conditions studied

Healthy

In context

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 45 Years to 64 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

Male, aged 45-64 years (both inclusive) at the time of signing informed consent
Body mass index (BMI) 20.0-29.9 kg/m\^2 (both inclusive)
Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion criteria

Exclusion Criteria:

Male of reproductive age who or whose partner(s) is not willing to use adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) for at least 4 months after dosing or male who is not willing to refrain from donating semen for at least 4 months after dosing. Acceptable forms of prevention include complete sexual abstinence, surgically sterilisation, that the subject uses a condom during intercourse or that the partner practices adequate contraception (risk of pregnancy must be lower than 1%).
Use of prescription or non-prescription products, including herbal products and non-routine vitamins, within 14 days prior to screening. Occasional use of paracetamol is permitted.
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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 7 participants (actual)

Study arms

Experimental
Somapacitan
Drug: somapacitan

Interventions

Drugsomapacitan
All subjects will receive one subcutaneous (s.c., under the skin) dose of somapacitan containing \[3H\]-somapacitan

What researchers measure

Primary outcomes

Total amount of [3H]-somapacitan related material excreted in urine (% of dose)
Time frame: Assessed up to 35 days after trial product administration
Total amount of [3H]-somapacitan related material excreted in faeces (% of dose)
Time frame: Assessed up to 35 days after trial product administration
Total amount of [3H]-somapacitan related material excreted in expired air (% of dose)
Time frame: Assessed up to 35 days after trial product administration

Secondary outcomes

Total recovery of administered 3H label (sum of urine, faeces and expired air)
Time frame: Assessed up to 36 days after trial product administration
Blood to plasma ratio of [3H]-somapacitan related material
Time frame: Assessed up to 36 days after trial product administration

Study locations

1 site

Novo Nordisk Investigational Site
Groningen, 9728 NZ, Netherlands

References and documents

Publications

Helleberg H, Bjelke M, Damholt BB, Pedersen PJ, Rasmussen MH. Absorption, metabolism and excretion of once-weekly somapacitan, a long-acting growth hormone derivative, after single subcutaneous dosing in human subjects. Eur J Pharm Sci. 2021 Dec 1;167:106030. doi: 10.1016/j.ejps.2021.106030. Epub 2021 Oct 1. PubMed 34601071 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02962440
Lead sponsor: Novo Nordisk A/S
Responsible party: Sponsor
First posted: Nov 11, 2016
Start date: Nov 2016
Primary completion: Jan 2017
Completion: Jan 2017
Last update: Jun 7, 2017

Study contacts

Global Clinical Registry (GCR, 1452)

study director · Novo Nordisk A/S

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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