A single center two part study in healthy adult male subjects to determine the human mass balance and pharmacokinetics of a single oral dose of 14C-KHK75801 (Part 1) and to assess the absolute bioavailability based on the pharmacokinetic parameters of a single intravenous microdose of 14CKHK7580 following a single oral dose of KHK7580 (Part 2)

A single center two part study in healthy adult male subjects to determine the human mass balance and pharmacokinetics of a single oral dose of 14C-KHK75801 (Part 1) and to assess the absolute bioavailability based on the pharmacokinetic parameters of a single intravenous microdose of 14CKHK7580 following a single oral dose of KHK7580 (Part 2) - KHK7580 mass balance and absolute bioavailability study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41144

Enrollment

Registered

2014-08-04

Start date

2014-08-12

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

chronic kidney diseases secondary hyperparathyroidism

Interventions

Part 1: During the study the volunteer will receive the study medication after a fasting period (no foods or drinks) of at least 10 hours as an oral solution of 100 milliliters. After administration

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 18-45 yrs, inclusive BMI: 18.0-30.0 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 60 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 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics (PK): Part 1 (Group 1): Plasma concentrations of KHK7580; total radioactivity concentrations in plasma, whole blood, urine and feces; PK parameters; metabolite profiling in plasma, urine and feces Part 2 (Group 2): Plasma concentrations of KHK7580 and parent associated 14C (14C KHK7580); total radioactivity concentrations in urine and feces; PK parameters	—

Secondary

Measure	Time frame
Safety: Adverse events, and results of vital signs, 12-lead electrocardiogram, clinical laboratory tests and physical examination Pharmacodynamics (PD): Calcium, inorganic phosphate and intact PTH	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)