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Study Investigating the Safety and Tolerability of Lu AF88434 in Healthy Young Men

Sponsor
H. Lundbeck A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT04082325
Collaborator
(none)
68
Enrollment
1
Location
4
Arms
14.1
Actual Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the effect of Lu AF88434 on the body and what the body does to Lu AF88434 and the effect of food after swallowing single oral doses

Condition or Disease Intervention/Treatment Phase
  • Drug: Lu AF88434
  • Drug: Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434)
  • Drug: Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434)
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-oral-dose Study Investigating the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Properties of Lu AF88434 and Open-label Crossover Study to Investigate the Intra-individual Variability, Metabolic Profile, and Effect of Food on Lu AF88434 in Healthy Young Men
Actual Study Start Date :
Jul 23, 2019
Actual Primary Completion Date :
Sep 24, 2020
Actual Study Completion Date :
Sep 24, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A Lu AF88434 or Placebo

6 cohorts (cohort A1 to A6) with 9 subjects in each cohort. In each cohort 6 subjects will receive single doses of Lu AF88434 and 3 subjects will receive placebo

Drug: Lu AF88434
Lu AF88434, single oral solution Starting dose will be 0.2 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).

Drug: Placebo
Placebo to Lu AF88434 oral solution, single dose
Experimental: Part B1 Lu AF88434 Fed-Fasting-Fasting

4 subjects will receive an identical oral dose of Lu AF88434 in Group B1. The treatment sequence for Group B1 is: Fed-Fasting-Fasting. 14C-spiked dose (Lu AF99723) will be given in the last treatment sequence.

Drug: Lu AF88434
Lu AF88434, single oral solution Starting dose will be 0.2 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).

Drug: Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434)
Oral solution
Experimental: Part B2 Lu AF88434 Fasting-Fed-Fasting

4 subjects will receive an identical oral dose of Lu AF88434 in Group B2. The treatment sequence for Group B2 is: Fasting-Fed-Fasting. 14C-spiked dose (Lu AF99722) will be given in the last treatment sequence.

Drug: Lu AF88434
Lu AF88434, single oral solution Starting dose will be 0.2 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).

Drug: Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434)
Oral solution
Experimental: Part B3 Lu AF88434 Fasting-Fasting-Fed

4 subjects will receive an identical oral dose of Lu AF88434 in Group B3. The treatment sequence for Group B3 is: Fasting-Fasting-Fed.

Drug: Lu AF88434
Lu AF88434, single oral solution Starting dose will be 0.2 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).

Outcome Measures

Primary Outcome Measures

  1. Number of participants with treatment-emergent adverse events [From screening to Day 11]

    Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters)

  2. Cmax Lu AF88434 [From 0 to 96 hours]

    Maximum observed plasma concentration

  3. AUC(0-inf) Lu AF88434 [From 0 to 96 hours]

    Area under the plasma concentration time curve from zero to infinity

  4. CL/F Lu AF88434 [From day 1 to day 5]

    Oral clearance for Lu AF88434 in plasma

  5. Cumulative recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose) [From 0 to Day 14]

  6. Total recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose) [From 0 to Day 14]

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 with a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit and Baseline Visit.

Exclusion Criteria:

  • The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.

  • For Part B: The subject has received radiolabelled material <12 months prior to the Screening Visit.

Other inclusion and exclusion criteria may apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 QPS Groningen Netherlands

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:
NCT04082325
Other Study ID Numbers:
  • 18144A
First Posted:
Sep 9, 2019
Last Update Posted:
Feb 24, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 24, 2021