NCT03670082

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2019

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

September 12, 2018

Last Update Submit

October 31, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Absolute bioavailability Fabs

    Fabs= 100\*(AUC0-72h, po\*Div) / (AUC0-72h, iv\*Dpo) (where D is the dose)

    0 to 120 hours

Secondary Outcomes (3)

  • AUC0-inf: area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours

    0 to 120 hours

  • Cmax: maximum observed plasma concentration

    0 to 120 hours

  • tmax: time at maximum observed plasma concentration

    0 to 120 hours

Study Arms (2)

Group 1: Fasting condition in Period I

EXPERIMENTAL

Subjects will be in fasting condition in Period I and in a fed condition in Period II.

Drug: Lu AF35700Drug: Lu AF35700 iv

Group 2: Fed condition in Period I

EXPERIMENTAL

Subjects will be in fed condition in Period I and in fasting condition in Period II.

Drug: Lu AF35700

Interventions

Lu AF35700DRUG

20 mg Lu AF35700 single oral dose

Group 1: Fasting condition in Period IGroup 2: Fed condition in Period I
Lu AF35700 ivDRUG

100 μg \[14C\]-Lu AF35700 (4.7 μCi/174 kBq) single intravenous micro-dose

Group 1: Fasting condition in Period I

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance

Leeds, United Kingdom

Location

MeSH Terms

Interventions

Lu AF35700

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@Lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 13, 2018

Study Start

September 5, 2018

Primary Completion

December 21, 2018

Study Completion

January 13, 2019

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations

GB(1)