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OpenTrials
Completed

NCT Number: NCT03103646

Study Evaluating the Effect of Multiple Doses of Itraconazole on the Drug Lu AF35700 in Healthy Young Men and Women

This study will investigate the effect of multiple doses of the strong P450 enzyme inhibitor itraconazole on the pharmacokinetics of Lu AF35700 in healthy subjects.

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Key information

Conditions

Cytochrome P450 Interaction

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit Ltd, Leeds, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Men, aged ≥18 and ≤55 years. body weight ≥50 kg
  • women, aged ≥18 and ≤45 years, body weight ≥50 kg
  • Good general health as assessed using detailed medical history, laboratory tests, and physical examination
  • Known CYP2D6 and CYP2C19 genotype

Exclusion criteria

  • Pregnant or lactating
  • Subject has previously been dosed with Lu AF35700

Other protocol defined inclusion and exclusion criteria may apply

Treatment and study plan

Lu AF35700

Drug

Tablets for oral use, single dose in a fasted state. EMs: 10 mg/day, PMs: 5 mg

Itraconazole (200 mg)

Drug

100 mg Capsules for oral use, 200 mg/day. In a fed state

Itraconazole (300 mg)

Drug

100mg Capsules for oral use, 300 mg/day. In a fasted state.

Primary outcomes

  1. AUC(0-inf)

    Time frame: Day 1: Predose to day 29 postdose, Day 32: Predose to day 74 postdose

    Area under the Lu AF35700 plasma concentration-time curve (with and without itraconazole) for CYP2D6 EMs

  2. Cmax

    Time frame: 0-24 hours postdose (Day 1 and day 32)

    Maximum observed plasma concentration of Lu AF35700 (with and without itraconazole) for CYP2D6 EMs

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional, Open-label, One-sequence Crossover Study Evaluating the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Pharmacokinetics, Safety and Tolerability of Lu AF35700 in Healthy Young Men and Women

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 6, 2017
Registry last updated
Oct 2, 2019

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.