Absolute Bioavailability of Lu AE58054 in Healthy Subjects

Phase 1CompletedNCT02019394

H. Lundbeck A/S10 enrolled

Overview

To determine the absolute bioavailability of the Lu AE58054 tablet formulation at steady state

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Lu AE58054DRUG

Oral dosing: 90 mg Lu AE58054 as a single dose once and after a 3 days washout period, once daily for 7 days. Intravenous dosing: 90 μg/not more than (NMT) 1000 nCi/37 kBq 14C-Lu AE58054 for intravenous infusion once on Day 10.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy men and women aged between 21-55 years (inclusive) and with an BMI in the range 18.5 to 32 kg/m2 (minimum weight 60 kg for men and 55 kg for women). * The subjects CYP2D6 genotype must be determined before inclusion into the study. * Women must not be pregnant or lactating. Exclusion Criteria: * The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason. Other inclusion and exclusion criteria may apply.

Locations (1)

GB803

Nottingham, United Kingdom

Outcomes

Primary Outcomes

Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IV

Intravenous (IV)

Time frame: Day 10

Ratio of (AUC0-24(PM)/AUC0-24(EM))

Poor Metaboliser (PM); Extensive Metaboliser (EM)

Time frame: Day 10

Secondary Outcomes

Number and frequency of adverse events

Standard clinical safety assessments

Time frame: Up to Day 16

Number of subjects with adverse events

Adverse event monitoring

Time frame: Up to Day 16

Risk of Suicidality

Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions

Time frame: Up to Day 16

Data from ClinicalTrials.gov

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