Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes

• Sponsor: H. Lundbeck A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03195946
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Actual Duration (Months): 6.6
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

This study will help determine which types of drugs that may interact with Lu AF35700

Condition or Disease	Intervention/Treatment	Phase
Drug Reactions	Drug: Lu AF35700; Drug: Midazolam; Drug: Cocktail of CYP450 substrates	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Interventional, Open-label, Multiple-dose Study to Investigate the Effects of Multiple Doses of Lu AF35700 on the Pharmacokinetics of Cytochrome P450 (CYP450) Substrates Dextromethorphan (CYP2D6), Caffeine (CYP1A2), Omeprazole (CYP2C19), and Midazolam (CYP3A4/5) in Healthy Young Adults
• Actual Study Start Date: Jun 16, 2017
• Actual Primary Completion Date: Jan 3, 2018
• Actual Study Completion Date: Jan 3, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lu AF35700 and Cocktail of CYP450 substrates Day 1 oral midazolam administration, Day 2 Cocktail of CYP450 substrates administration. Daily Lu AF35700 administration from Day 5 to Day 28 with co-administration on Day 27 with oral midazolam and Day 28 with CYP450 substrate cocktail	Drug: Lu AF35700; tablets for oral use, 10 mg/day; Drug: Midazolam; syrup for oral use, 4mg/day; Drug: Cocktail of CYP450 substrates; Caffeine tablets for oral use, 200 mg/day. Omeprazole tablets for oral use, 40 mg/day. Dextromethorphan tablets for oral use, 30 mg/day. Midazolam IV solution for Intravenous use, 0.025 mg/kg/day

Outcome Measures

Primary Outcome Measures

1. AUC(0-inf): Area under the plasma concentration-time curve from zero to infinity [Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for cocktail components.]

   Area under the plasma concentration-time curve from zero to infinity for oral midazolam and metabolite and all drug cocktail components and their metabolites

2. Cmax: Maximum observed concentration [Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for Cocktail components.]

   Maximum observed concentration of oral midazolam and all drug cocktail components and their metabolites

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Body weight at least 50 kg and Body Mass Index 19 - 30 kg/m2

• Good general health ascertained by a detailed medical history, laboratory tests and physical examination

Exclusion Criteria:

-Pregnant or lactating women

Other protocol defined inclusion and exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research Unit Ltd	Leeds		United Kingdom

Sponsors and Collaborators

• H. Lundbeck A/S

Investigators

• Study Director: Email contact via H. Lundbeck A/S, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: H. Lundbeck A/S
• ClinicalTrials.gov Identifier: NCT03195946
• Other Study ID Numbers: 17200A; 2016-003187-39
• First Posted: Jun 22, 2017
• Last Update Posted: Jan 8, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Drug-Related Side Effects and Adverse Reactions; Midazolam

Study Results

No Results Posted as of Jan 8, 2018