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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03670082

Enrollment

Registered

2018-09-13

Start date

2018-09-05

Completion date

2019-01-13

Last updated

2019-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

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.

Interventions

DRUGLu AF35700

20 mg Lu AF35700 single oral dose

DRUGLu AF35700 iv

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Absolute bioavailability Fabs	0 to 120 hours	Fabs= 100\(AUC0-72h, po\Div) / (AUC0-72h, iv\*Dpo) (where D is the dose)

Secondary

Measure	Time frame	Description
AUC0-inf: area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours	0 to 120 hours	Area under the plasma concentration-time curve from zero to 72 hours for Lu AF35700
Cmax: maximum observed plasma concentration	0 to 120 hours	Maximum observed plasma concentration of Lu AF35700
tmax: time at maximum observed plasma concentration	0 to 120 hours	Time at which maximum observed plasma concentration of Lu AF35700 occurred

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026