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Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03670082
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Description
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Brief Summary:
The purpose of this study is to investigate the extent to which Lu AF35700 enters the bloodstream following pill intake and the influence of food on the uptake in healthy men and women

Condition or disease Intervention/treatment Phase
Healthy Drug: Lu AF35700 Drug: Lu AF35700 iv Phase 1

Detailed Description:

Each subject will receive a single oral dose of Lu AF35700 on Day 1 in each Period. Subjects in Group 1 will be in fasting condition in Period I and in a fed condition in Period II. Subjects in Group 2 will be in fed condition in Period I and in fasting condition in Period II.

For Group 1, period 1 only, a single intravenous micro-dose of Lu AF35700 will be given 4 hours after oral dosing.

All subjects will be confined to the clinic from one day prior to the first dosing until Day 6 (120 hours post dose) for each dosing period. Periods I and II will be separated by a period of 6 weeks.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventional, Open-label, Two-way Crossover, Single-dose Study Investigating the Absolute Bioavailability and Food Effect on the Pharmacokinetics of Lu AF35700 in Healthy Subjects
Actual Study Start Date : September 5, 2018
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : January 13, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1: Fasting condition in Period I
Subjects will be in fasting condition in Period I and in a fed condition in Period II.
 Drug: Lu AF35700
20 mg Lu AF35700 single oral dose

Drug: Lu AF35700 iv
100 μg [14C]-Lu AF35700 (4.7 μCi/174 kBq) single intravenous micro-dose
Experimental: Group 2: Fed condition in Period I
Subjects will be in fed condition in Period I and in fasting condition in Period II.
 Drug: Lu AF35700
20 mg Lu AF35700 single oral dose


Outcome Measures
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Primary Outcome Measures :
  1. Absolute bioavailability Fabs [ Time Frame: 0 to 120 hours ]
    Fabs= 100*(AUC0-72h, po*Div) / (AUC0-72h, iv*Dpo) (where D is the dose)


Secondary Outcome Measures :
  1. AUC0-inf: area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours [ Time Frame: 0 to 120 hours ]
    Area under the plasma concentration-time curve from zero to 72 hours for Lu AF35700

  2. Cmax: maximum observed plasma concentration [ Time Frame: 0 to 120 hours ]
    Maximum observed plasma concentration of Lu AF35700

  3. tmax: time at maximum observed plasma concentration [ Time Frame: 0 to 120 hours ]
    Time at which maximum observed plasma concentration of Lu AF35700 occurred


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men and women aged ≥18 and ≤55 years
  • Body Mass Index (BMI) of ≥18.5 and ≤30 kg/m2
  • Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination

Exclusion Criteria:

  • The subject must not be of childbearing potential (if a woman) or should use contraception, be surgically sterilized or not be sexually active (both sexes). Women must not be pregnant or lactating
  • The subject must not be a CYP2D6 or a CYP2C19 poor metabolizer

Other inclusion and exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670082


Locations
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United Kingdom
Covance
Leeds, United Kingdom
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
More Information
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT03670082    
Other Study ID Numbers: 17482A
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No