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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.

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