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Safety and Tolerability of Lu AG06479 in Healthy Young Men

NCT ID: NCT04473651

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-09

Study Completion Date

2021-11-10

Brief Summary

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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.

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Detailed Description

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Part A: randomized, sequential

Part B: open-label, cross-over

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A: Single dose of Lu AG06479 or Placebo

Group Type EXPERIMENTAL

Lu AG06479

Intervention Type DRUG

capsules, orally (Part A and B)

Placebos

Intervention Type DRUG

Placebo - capsules, orally (Part A only)

Part B: Repeated dose of Lu AG06479 and Food interaction

Sequence B1: Fed - Fasting - Fasting

Sequence B2: Fasting- Fed - Fasting

Sequence B3: Fasting- Fasting - Fed

Group Type EXPERIMENTAL

Lu AG06479

Intervention Type DRUG

capsules, orally (Part A and B)

Interventions

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Lu AG06479

capsules, orally (Part A and B)

Intervention Type DRUG

Placebos

Placebo - capsules, orally (Part A only)

Intervention Type DRUG

Other Intervention Names

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ABX-1762

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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Covance

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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18452A

Identifier Type: -

Identifier Source: org_study_id

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