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

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

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.

Study Overview

• Status: Completed
• Conditions: Cytochrome P450 Interaction
• Intervention / Treatment: Drug: Lu AF35700; Drug: Itraconazole (200 mg); Drug: Itraconazole (300 mg)

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom
    • Covance Clinical Research Unit Ltd
• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance - Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lu AF35700; Day 1: Single dose of Lu AF35700. Extensive metabolisers (EMs): 10mg. Poor metabolisers (PMs): 5 mg	Drug: Lu AF35700; Tablets for oral use, single dose in a fasted state. EMs: 10 mg/day, PMs: 5 mg
Experimental: Lu AF35700 AND itraconazole; Days 29 to 31: once-daily dosage of 200 mg itraconazole. Day 32: Single dose of Lu AF35700 (EMs: 10 mg, PMs: 5 mg) and 300 mg itraconazole Days 33 to 42: once-daily dosage of 200 mg itraconazole	Drug: Lu AF35700; Tablets for oral use, single dose in a fasted state. EMs: 10 mg/day, PMs: 5 mg; Drug: Itraconazole (200 mg); 100 mg Capsules for oral use, 200 mg/day. In a fed state; Drug: Itraconazole (300 mg); 100mg Capsules for oral use, 300 mg/day. In a fasted state.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Cmax	Maximum observed plasma concentration of Lu AF35700 (with and without itraconazole) for CYP2D6 EMs	0-24 hours postdose (Day 1 and day 32)

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2017
• Primary Completion (Actual): April 14, 2019
• Study Completion (Actual): July 19, 2019

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Actual): October 2, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole; Hydroxyitraconazole
• Other Study ID Numbers: 17208A; 2016-003302-14 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No