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Safety and Tolerability of Lu AF95245 in Healthy Young Men
Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending Oral Dose Study Investigating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Lu AF95245 and Open-label Crossover Study to Investigate Intra-subject Variability, Effect of Food on Lu AF95245, and Metabolic Profile of [14C]-Lu AF95245 in Healthy Young Men
1 other identifier
interventional
18
1 country
1
Brief Summary
The purpose of this study is to investigate the safety and tolerability of Lu AF95245 and what the body does to Lu AF95245 after swallowing single doses of the drug
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 Dec 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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2019
CompletedFirst Submitted
Initial submission to the registry
December 12, 2019
CompletedFirst Posted
Study publicly available on registry
December 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2020
CompletedMay 12, 2020
May 1, 2020
2 months
December 12, 2019
May 11, 2020
Conditions
Outcome Measures
Primary Outcomes (5)
Number of participants with treatment-emergent adverse events
Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)
From baseline to Day 14
AUC(0-inf) Lu AF95245
Area under the plasma concentration time curve from zero to infinity
From 0 to 96 hours
Cmax Lu AF95245
Maximum observed plasma concentration
From 0 to 96 hours
CL/F Lu AF95245
Oral clearance for Lu AF95245 in plasma
From 0 to 96 hours
Total recovery of the administered dose (% of dose in urine and faeces)
Excretion of labelled Lu AF95245 in urine and faeces
From 0 to Day 14
Study Arms (2)
Cohort A: single-ascending oral dose
EXPERIMENTALCohorts A1 to A6, single ascending dose, with 9 subjects in each cohort, sequential
Cohort B: (fasting/fed conditions)
EXPERIMENTALGroups B1, B2, and B3, with 4 subjects in each group and the groups will be running in parallel. B1: fed-fasting-fasting condition (spiked dosage) B2: fasting-fed-fasting condition (spiked dosage) B3: fasting-fasting-fed condition
Interventions
solution, single dose, orally
solution, single dose, orally
Eligibility Criteria
You may qualify if:
- Healthy, young, non-smoking men with a body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2 at the Screening Visit.
You may not qualify if:
- The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the IMP.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (1)
QPS Netherlands BV
Groningen, Netherlands
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2019
First Posted
December 16, 2019
Study Start
December 10, 2019
Primary Completion
February 16, 2020
Study Completion
February 19, 2020
Last Updated
May 12, 2020
Record last verified: 2020-05