D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound

Interventional, Open-label, Positron Emission Tomography (PET) Study Investigating D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02093169

Enrollment

Registered

2014-03-20

Start date

2014-02-28

Completion date

Unknown

Last updated

2014-09-23

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

Conditions

Healthy Men

Brief summary

To investigate the relationship between the combined Lu AF35700 and Lu AF36152 plasma concentration and D2 dopamine receptor occupancy up to 172 hours after oral dosing of Lu AF35700

Interventions

DRUGPart A: Lu AF35700

One 30 mg single dose for one day; orally

DRUGPart B: Lu AF35700

Daily dosing: 10 mg for 3 days, 20 mg for 3 days, 45 mg on Day 7; orally

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

25 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy young men \>=25 and \<=45 years of age with a Body Mass Index (BMI) \>=18.5 kg/m2 and \<=30 kg/m2. Other protocol-defined Inclusion and

Exclusion criteria

may apply.

Design outcomes

Primary

Measure	Time frame
Relationship between plasma concentrations and pharmacodynamic (PD) measures specified as binding potential at each scanning time point	Up to 172 hours after dosing
Relationship between plasma concentrations and PD measures specified as plasma concentrations of Lu AF35700, Lu AF36152 and Lu AF35700 + Lu AF36152 at each scanning time point	Up to 172 hours after dosing
Relationship between plasma concentrations and PD measures specified as occupancy in relation to plasma concentrations of Lu AF35700, Lu AF36152 and Lu AF35700 + Lu AF36152, respectively	Up to 172 hours after dosing

Secondary

Measure	Time frame
Adverse events	Up to Week 12
Columbia Suicide Severity Rating Scale (C-SSRS) (Part B only)	Up to Week 12
Area under the curve (AUC), maximum observed concentration (Cmax), oral clearance (CL/F), and apparent elimination half-life (t½)	Up to 168 hours after dosing

Countries

United Kingdom

Outcome results

None listed

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