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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Lu AF88434; Drug: Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434); Drug: Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04082325

18144A

Details and patient eligibility

About

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

Enrollment: 68 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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68 participants in 4 patient groups

Part A Lu AF88434 or Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Lu AF88434

Part B1 Lu AF88434 Fed-Fasting-Fasting

Experimental group

Description:

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.

Treatment:

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

Drug: Lu AF88434

Part B2 Lu AF88434 Fasting-Fed-Fasting

Experimental group

Description:

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.

Treatment:

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

Drug: Lu AF88434

Part B3 Lu AF88434 Fasting-Fasting-Fed

Experimental group

Description:

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

Treatment:

Drug: Lu AF88434