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

H. Lundbeck A/S68 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

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).

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

Oral solution

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

Oral solution

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

QPS

Groningen, Netherlands

Outcomes

Primary Outcomes

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)

Time frame: From screening to Day 11

Cmax Lu AF88434

Maximum observed plasma concentration

Time frame: From 0 to 96 hours

AUC(0-inf) Lu AF88434

Area under the plasma concentration time curve from zero to infinity

Time frame: From 0 to 96 hours

CL/F Lu AF88434

Oral clearance for Lu AF88434 in plasma

Time frame: From day 1 to day 5

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

Time frame: From 0 to Day 14

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

Time frame: From 0 to Day 14

Data from ClinicalTrials.gov

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