A single centre, open label trial investigating the absorption, metabolism and excretion of somapacitan after single subcutaneous dosing in healthy male subjects

Completed

• Conditions: groeihormoondeficientie; growth hormone deficiency

• Registration Number: NL-OMON42854
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 7

Inclusion Criteria

healthy male subjects
45-64 yrs, inclusive
BMI: 20.0-29.9 kg/m2, inclusive

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 400 mL of blood in the 90 days prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints will be total radioactivity excreted in urine, faeces,<br /><br>and expired air (% of dose) assessed up to 35 days after trial product<br /><br>administration:<br /><br><br /><br>- Total amount of [3H]-somapacitan related material excreted in urine (% of<br /><br>dose)<br /><br>- Total amount of [3H]-somapacitan related material excreted in faeces (% of<br /><br>dose)<br /><br>- Total amount of [3H]-somapacitan related material excreted in expired air (%<br /><br>of dose)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To be calculated from first administration of trial product and up until day 36<br /><br>(final visit):<br /><br><br /><br>- Total recovery of administered 3H label (sum of urine, faeces and expired air)<br /><br>- Blood to plasma ratio of [3H]-somapacitan related material</p><br>