Skip to main content
OpenTrials
Completed

NCT Number: NCT02122692

Effect of Multiple Doses of Itraconazole on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects

To examine the effect of the strong CYP3A4/5 inhibitor itraconazole (200 mg QD) on the multipledose exposure of Lu AE58054 (30 mg QD) in healthy subjects (CYP2D6 extensive metabolisers).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

FR801

Rennes, 35042, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects are eligible for inclusion into the study if they meet each of the following criteria:

  • Men and women, aged 18 - 45 years.
  • Body weight at least 50 kg and Body Mass index 19 - 28 kg/m2.
  • Good general health ascertained by a detailed medical history, laboratory tests and physical examination.
  • Non-childbearing potential or use of contraception (both sexes).
  • Women must not be pregnant or lactating.
  • Known CYP2D6 genotype (Extensive metaboliser (n=15) and poor metaboliser (n =5)) .

Other Inclusion and Exclusion Criteria may apply.

Treatment and study plan

Lu AE58054 30 mg

Drug

Lu AE58054 encapsulated film-coated tablets, once daily, Day 1-5, orally

Lu AE58054 30 mg + itraconazole 200 mg

Drug

Lu AE58054 encapsulated film-coated tablets, once daily, Day 6-11, orally + itraconazole capsules, once daily, Day 6-11, orally

Itraconazole

Drug

Itraconazole capsules, once daily, Day 12-13, orally

Primary outcomes

  1. Area under the Lu AE58054 plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)

    Time frame: Day 5 and Day 11

  2. Maximum observed concentration (Cmax) of Lu AE58054

    Time frame: Day 5 and Day 11

Secondary outcomes

  1. Plasma pharmacokinetics for Lu AE58054: AUC0-24, Cmax, time at which maximum observed plasma concentration occurred (tmax), apparent oral clearance (CL/F), half life (t½) and apparent volume of distribution Vz/F

    Time frame: Day 5 and Day 11

  2. Plasma pharmacokinetics for relevant metabolites: AUC0-24, Cmax, tmax, t½ and metabolic ratio (MR)

    Time frame: Day 5 and Day 11

  3. Plasma pharmacokinetic parameters for itraconazole: CTrough

    Time frame: Day 6 to Day 13

  4. Adverse events

    Time frame: Up to Day 18, including a safety follow-up

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

    Time frame: Up to Day 18, including a safety follow-up

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional, Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects

Important dates

Study start
2014
Primary completion
2014
First posted
Apr 24, 2014
Registry last updated
Jun 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.