What the Body Does to Foliglurax in Healthy Volunteers

Healthy Clinical Trial

— Foliglurax  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04002895
• Other study ID #: 18154A
• Status: Completed
• Phase: Phase 1
• Start date: June 27, 2019
• Est. completion date: August 8, 2019

Study information

• Verified date: November 2019
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 8, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United Kingdom	GB1050 Covance	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of radioactivity excreted	Cumulative amount of radioactivity excreted in urine and faeces	Before dosing until day 11
Primary	AUC(0-inf) foliglurax	Area under the plasma concentration time curve from zero to infinity	From day 1 until day 11
Primary	Cmax foliglurax	Maximum observed plasma concentration	From day 1 until day 11
Primary	CL/F foliglurax	Oral clearance for foliglurax in plasma	From Day 1 until Day 11
Primary	Total recovery of the administered dose	% of dose in urine and faeces	Before dosing until day 11