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Safety and Tolerability of Lu AG06479 in Healthy Young Men

Sponsor
H. Lundbeck A/S (Industry)
Overall Status
Terminated
CT.gov ID
NCT04473651
Collaborator
(none)
46
Enrollment
1
Location
2
Arms
16.1
Actual Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lu AG06479
  • Drug: Placebos
 Phase 1

Detailed Description

Part A: randomized, sequential

Part B: open-label, cross-over

Study Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Interventional, Randomized, Double-blind, Placebo-controlled, Sequential-group, Single-ascending Oral Dose Study Investigating the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of Lu AG06479 and Open-label Cross-over Study to Investigate Intra-subject Variability and Effect of Food in Healthy Young Men
Actual Study Start Date :
Jul 9, 2020
Actual Primary Completion Date :
Nov 10, 2021
Actual Study Completion Date :
Nov 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A: Single dose of Lu AG06479 or Placebo

Drug: Lu AG06479
capsules, orally (Part A and B)
Other Names:
  • ABX-1762

    • Drug: Placebos
    Placebo - capsules, orally (Part A only)
    Experimental: 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

    Drug: Lu AG06479
    capsules, orally (Part A and B)
    Other Names:
  • ABX-1762

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with treatment emergent adverse events (Safety and Tolerability) [From baseline to Day 9 (Part A and B)]

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

    Secondary Outcome Measures

    1. AUC (0-inf) of Lu AG06479 [From pre-dose to Day 5 (Part A and B)]

      Area under the Lu AG06479 concentration-time curve from time zero to infinity (AUC0-inf)

    2. CL/F Lu AG06479 [From pre-dose to Day 5 (Part A and B)]

      Oral clearance of Lu AG06479

    3. Cmax Lu AG06479 [From pre-dose to Day 5 (Part A and B)]

      Maximum observed plasma concentration for Lu AG06479

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Other in- and exclusion criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Covance Madison Wisconsin United States 53704

    Sponsors and Collaborators

    • H. Lundbeck A/S

    Investigators

    • Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    H. Lundbeck A/S
    ClinicalTrials.gov Identifier:
    NCT04473651
    Other Study ID Numbers:
    • 18452A
    First Posted:
    Jul 16, 2020
    Last Update Posted:
    Dec 14, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Dec 14, 2021