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Single Dose of Lu AF28996 to Healthy Young Men

NCT03565094 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2019-09-26

No results posted yet for this study

Summary

This study evaluates how increasing doses of Lu AF28996 enters, moves through and exits the body when given by mouth to healthy young men.

Conditions

  • Healthy

Interventions

DRUG

Lu AF28996 solution

Oral solution (0.1-0.2 mg/mL) Following each cohort, a dosing conference will be held where tolerability, safety and preliminary PK results from the previous cohorts will be reviewed before deciding on the next doses

DRUG

Lu AF28996 capsule

hard capsule orally QD: one dose lower than the highest dose level in part A

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-05-29
Primary Completion
2019-08-17
Completion
2019-08-21

Countries

  • Netherlands

Study Locations

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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 NCT03565094 on ClinicalTrials.gov