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Completed

NCT Number: NCT04002895

What the Body Does to Foliglurax in Healthy Volunteers

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

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Key information

Conditions

Healthy

Age range

45 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GB1050 Covance

Leeds, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Foliglurax

Drug

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

Primary outcomes

  1. Total amount of radioactivity excreted

    Time frame: Before dosing until day 11

    Cumulative amount of radioactivity excreted in urine and faeces

  2. AUC(0-inf) foliglurax

    Time frame: From day 1 until day 11

    Area under the plasma concentration time curve from zero to infinity

  3. Cmax foliglurax

    Time frame: From day 1 until day 11

    Maximum observed plasma concentration

  4. CL/F foliglurax

    Time frame: From Day 1 until Day 11

    Oral clearance for foliglurax in plasma

  5. Total recovery of the administered dose

    Time frame: Before dosing until day 11

    % of dose in urine and faeces

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional, Open-label, Single-dose Study Investigating the Absorption, Metabolism and Excretion (AME) of Foliglurax (Lu AF99757) Following Oral Dosing of 14C-foliglurax to Healthy Men

Acronym: Foliglurax

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 1, 2019
Registry last updated
Nov 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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