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

A single centre, open label trial investigating the absorption, metabolism and excretion of somapacitan after single subcutaneous dosing in healthy male subjects - Somapacitan 3H-AME study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42854

Enrollment

Registered

2016-10-25

Start date

2016-11-11

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

groeihormoondeficientie growth hormone deficiency

Interventions

The volunteer will receive a single dose of 6 mg radiolabeled somapacitan as a sc injection.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)