NCT04473651

Brief Summary

The purpose of this study is to investigate the safety and tolerability of Lu AG06479 and what the body does to Lu AG06479 after swallowing single doses of the drug.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2020

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

July 9, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2021

Completed
Last Updated

December 14, 2021

Status Verified

November 1, 2021

Enrollment Period

1.3 years

First QC Date

July 13, 2020

Last Update Submit

November 30, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment emergent adverse events (Safety and Tolerability)

    Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight and ECG parameters)

    From baseline to Day 9 (Part A and B)

Secondary Outcomes (3)

  • AUC (0-inf) of Lu AG06479

    From pre-dose to Day 5 (Part A and B)

  • CL/F Lu AG06479

    From pre-dose to Day 5 (Part A and B)

  • Cmax Lu AG06479

    From pre-dose to Day 5 (Part A and B)

Study Arms (2)

Part A: Single dose of Lu AG06479 or Placebo

EXPERIMENTAL
Drug: Lu AG06479Drug: Placebos

Part B: Repeated dose of Lu AG06479 and Food interaction

EXPERIMENTAL

Sequence B1: Fed - Fasting - Fasting Sequence B2: Fasting- Fed - Fasting Sequence B3: Fasting- Fasting - Fed

Drug: Lu AG06479

Interventions

Lu AG06479DRUG

capsules, orally (Part A and B)

Also known as: ABX-1762
Part A: Single dose of Lu AG06479 or PlaceboPart B: Repeated dose of Lu AG06479 and Food interaction
PlacebosDRUG

Placebo - capsules, orally (Part A only)

Part A: Single dose of Lu AG06479 or Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, young, non-smoking men, weight ≥60 kg, and a body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2 at the Screening Visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance

Madison, Wisconsin, 53704, United States

Location

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@Lundbeck.com

    STUDY DIRECTOR

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

July 13, 2020

First Posted

July 16, 2020

Study Start

July 9, 2020

Primary Completion

November 10, 2021

Study Completion

November 10, 2021

Last Updated

December 14, 2021

Record last verified: 2021-11

Locations

US(1)