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Study Investigating the Safety and Tolerability of Lu AF88434 in Healthy Young Men

NCT04082325 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2021-02-24

No results posted yet for this study

Summary

This study evaluates the effect of Lu AF88434 on the body and what the body does to Lu AF88434 and the effect of food after swallowing single oral doses

Conditions

  • Healthy

Interventions

DRUG

Lu AF88434

Lu AF88434, single oral solution Starting dose will be 0.2 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).

DRUG

Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434)

Oral solution

DRUG

Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434)

Oral solution

DRUG

Placebo

Placebo to Lu AF88434 oral solution, single dose

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-23
Primary Completion
2020-09-24
Completion
2020-09-24

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04082325 on ClinicalTrials.gov