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

Cytochrome P450 Interaction Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103646
• Other study ID #: 17208A
• Secondary ID: 2016-003302-14
• Status: Completed
• Phase: Phase 1
• Start date: March 28, 2017
• Est. completion date: July 19, 2019

Study information

• Verified date: October 2019
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 19, 2019
• Est. primary completion date: April 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cytochrome P450 Interaction

Intervention

Drug:
• Lu AF35700
Tablets for oral use, single dose in a fasted state. EMs: 10 mg/day, PMs: 5 mg
• Itraconazole (200 mg)
100 mg Capsules for oral use, 200 mg/day. In a fed state
• Itraconazole (300 mg)
100mg Capsules for oral use, 300 mg/day. In a fasted state.

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit Ltd	Leeds
United States	Covance - Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC(0-inf)	Area under the Lu AF35700 plasma concentration-time curve (with and without itraconazole) for CYP2D6 EMs	Day 1: Predose to day 29 postdose, Day 32: Predose to day 74 postdose
Primary	Cmax	Maximum observed plasma concentration of Lu AF35700 (with and without itraconazole) for CYP2D6 EMs	0-24 hours postdose (Day 1 and day 32)