What the Body Does to Foliglurax in Healthy Volunteers

H. Lundbeck A/S6 enrolled

Overview

This study evaluates how the body takes up and gets rid of foliglurax after swallowing a liquid dose.

Six healthy men will swallow a liquid dose of 80 mg that is labelled with a small dose of radioactive tracer. Blood, urine and faeces will be collected to measure how much of the radioactivity gets into the blood stream and ends up in the urine and faeces. It is also measured how the body gets rid of the radioactivity and how quickly.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

FoligluraxDRUG

Single oral dose of 80 mg \[14C\]-foliglurax(93µCi/3.44 MBq), 1mg/mL oral solution (prepared from \[14C\]-foliglurax powder for oral solution)

Eligibility

Sex: MALEMin age: 45 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: \- Healthy men with a body mass index (BMI) of 19-30 kg/m2 (inclusive), and with a body weight of minimum 60 kg at the Screening Visit. Exclusion Criteria: \- The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder. Other inclusion and exclusion criteria may apply.

Locations (1)

GB1050 Covance

Leeds, United Kingdom

Outcomes

Primary Outcomes

Total amount of radioactivity excreted

Cumulative amount of radioactivity excreted in urine and faeces

Time frame: Before dosing until day 11

AUC(0-inf) foliglurax

Area under the plasma concentration time curve from zero to infinity

Time frame: From day 1 until day 11

Cmax foliglurax

Maximum observed plasma concentration

Time frame: From day 1 until day 11

CL/F foliglurax

Oral clearance for foliglurax in plasma

Time frame: From Day 1 until Day 11

Total recovery of the administered dose

% of dose in urine and faeces

Time frame: Before dosing until day 11

Data from ClinicalTrials.gov

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