What the Body Does to Foliglurax in Healthy Volunteers
Foliglurax
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
1 other identifier
interventional
6
1 country
1
Brief Summary
This study evaluates how the body takes up and gets rid of foliglurax after swallowing a liquid dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Jun 2019
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2019
CompletedStudy Start
First participant enrolled
June 27, 2019
CompletedFirst Posted
Study publicly available on registry
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2019
CompletedNovember 4, 2019
November 1, 2019
1 month
June 27, 2019
November 1, 2019
Conditions
Outcome Measures
Primary Outcomes (5)
Total amount of radioactivity excreted
Cumulative amount of radioactivity excreted in urine and faeces
Before dosing until day 11
AUC(0-inf) foliglurax
Area under the plasma concentration time curve from zero to infinity
From day 1 until day 11
Cmax foliglurax
Maximum observed plasma concentration
From day 1 until day 11
CL/F foliglurax
Oral clearance for foliglurax in plasma
From Day 1 until Day 11
Total recovery of the administered dose
% of dose in urine and faeces
Before dosing until day 11
Study Arms (1)
Foliglurax
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- \- 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.
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (1)
GB1050 Covance
Leeds, United Kingdom
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2019
First Posted
July 1, 2019
Study Start
June 27, 2019
Primary Completion
August 1, 2019
Study Completion
August 8, 2019
Last Updated
November 4, 2019
Record last verified: 2019-11