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

Completed · Phase 1

Conditions studied: Cytochrome P450 Interaction

In brief

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.

Key facts

Study ID

NCT03103646

Run by

H. Lundbeck A/S

People needed

22

Starts

2017-03-28

Expected to finish

2019-07-19

Last updated by the study team

2019-10-02

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Pregnant or lactating
• Subject has previously been dosed with Lu AF35700
• Other protocol defined inclusion and exclusion criteria may apply

Where it is running

• Covance - Dallas — Dallas, Texas, United States
• Covance Clinical Research Unit Ltd — Leeds, United Kingdom

Full record on ClinicalTrials.gov

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