Absolute Bioavailability of Lu AE58054 in Healthy Subjects

Healthy Clinical Trial

Official title:

Interventional, Open-label Study Investigating the Absolute Bioavailability of Lu AE58054 After Multiple Oral Dosing and a Single Radio-labelled Intravenous Micro-dose as Well as the Contribution of Cytochrome P450 2D6 to the Exposure of Lu AE58054 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02019394
• Other study ID #: 14915A
• Secondary ID: 2012-005646-37
• Status: Completed
• Phase: Phase 1
• First received: December 18, 2013
• Last updated: March 20, 2014
• Start date: December 2013

Study information

• Verified date: March 2014
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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.

Study Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lu AE58054
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.

Locations

Country	Name	City	State
United Kingdom	GB803	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IV	Intravenous (IV)	Day 10	No
Primary	Ratio of (AUC0-24(PM)/AUC0-24(EM))	Poor Metaboliser (PM); Extensive Metaboliser (EM)	Day 10	No
Secondary	Number and frequency of adverse events	Standard clinical safety assessments	Up to Day 16	Yes
Secondary	Number of subjects with adverse events	Adverse event monitoring	Up to Day 16	Yes
Secondary	Risk of Suicidality	Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions	Up to Day 16	Yes