NCT04082325

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jul 2019

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

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 23, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2020

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

1.2 years

First QC Date

September 5, 2019

Last Update Submit

February 23, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

  • Number of participants with treatment-emergent adverse events

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

    From screening to Day 11

  • Cmax Lu AF88434

    Maximum observed plasma concentration

    From 0 to 96 hours

  • AUC(0-inf) Lu AF88434

    Area under the plasma concentration time curve from zero to infinity

    From 0 to 96 hours

  • CL/F Lu AF88434

    Oral clearance for Lu AF88434 in plasma

    From day 1 to day 5

  • Cumulative recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose)

    From 0 to Day 14

  • Total recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose)

    From 0 to Day 14

Study Arms (4)

Part A Lu AF88434 or Placebo

EXPERIMENTAL

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 AF88434Drug: Placebo

Part B1 Lu AF88434 Fed-Fasting-Fasting

EXPERIMENTAL

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 AF88434Drug: Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434)

Part B2 Lu AF88434 Fasting-Fed-Fasting

EXPERIMENTAL

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 AF88434Drug: Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434)

Part B3 Lu AF88434 Fasting-Fasting-Fed

EXPERIMENTAL

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

Interventions

Lu AF88434DRUG

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).

Part A Lu AF88434 or PlaceboPart B1 Lu AF88434 Fed-Fasting-FastingPart B2 Lu AF88434 Fasting-Fed-FastingPart B3 Lu AF88434 Fasting-Fasting-Fed
Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434)DRUG

Oral solution

Part B2 Lu AF88434 Fasting-Fed-Fasting
Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434)DRUG

Oral solution

Part B1 Lu AF88434 Fed-Fasting-Fasting
PlaceboDRUG

Placebo to Lu AF88434 oral solution, single dose

Part A Lu AF88434 or Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QPS

Groningen, Netherlands

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

September 5, 2019

First Posted

September 9, 2019

Study Start

July 23, 2019

Primary Completion

September 24, 2020

Study Completion

September 24, 2020

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations

NL(1)