Trial Outcomes & Findings for Positron Emission Tomography (PET) Study Investigating Dopamine and Serotonin Receptor Occupancy After Multiple Oral Dosing of Lu AF35700 (NCT NCT02333487)

NCT ID: NCT02333487

Last Updated: 2020-05-12

Results Overview

Maximal target occupancy (Emax) on the D1 dopamine receptor using PET with \[11C\]-NNC 112 tracer compound. The relationship between systemic exposure of Lu AF35700 and D1 dopamine occupancy was investigated using an Emax model containing the regression parameters maximal target occupancy (Emax) and plasma concentration which gives 50% of Emax (EC50). Both Emax and EC50 were estimated using one model for all post-baseline scans combined. No statistical testing was performed.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 22 participants
• Primary outcome timeframe: Change from baseline to 344 hours post last dose
• Results posted on: 2020-05-12

Participant Flow

The study consisted of 6 to 8 patients assigned to one of 3 groups (D1, D2, or 5-HT6). Each group characterising the Lu AF35700 plasma concentration/receptor occupance (RO) relationship of 1 of 3 receptors using 1 of 3 ligands: Group D1 using [11C]-NNC 112, Group D2 using [11C]-raclopride, and Group 5-HT6 using [11C]-Lu AE60157

Participant milestones

Measure	Lu AF35700 (Group D1) Lu AF35700: Daily dosing for up to 21 days (10 mg for 21 days for Cohort A1, 10 mg for 3 days and 15 mg for 18 days for Cohort A2, and 10 mg for 3 days and 20 mg for 17 days for Cohort A3). D1 receptor occupancy measured using \[11C\]-NNC 112.	Lu AF35700 (Group D2) Lu AF35700: Daily dosing for 21 days (10 mg for 3 days and 20 mg for 18 days). D2 receptor occupancy measured using \[11C\]-raclopride.	Lu AF35700 (Group 5-HT6) Lu AF35700: Cohort C1: Daily dosing with 10 mg for 21 days, Cohort C2: Daily dosing with 5 mg for 21 days, Cohort C3: Daily dosing with 5 mg for 7 days, Cohort C4: Dosing with 5 mg for 4 days (Days 1, 3, 5, and 7). 5-HT6 receptor occupancy measured using \[11C\]-Lu AE60157.
Overall Study STARTED	6	8	8
Overall Study COMPLETED	6	6	8
Overall Study NOT COMPLETED	0	2	0

Reasons for withdrawal

Measure	Lu AF35700 (Group D1) Lu AF35700: Daily dosing for up to 21 days (10 mg for 21 days for Cohort A1, 10 mg for 3 days and 15 mg for 18 days for Cohort A2, and 10 mg for 3 days and 20 mg for 17 days for Cohort A3). D1 receptor occupancy measured using \[11C\]-NNC 112.	Lu AF35700 (Group D2) Lu AF35700: Daily dosing for 21 days (10 mg for 3 days and 20 mg for 18 days). D2 receptor occupancy measured using \[11C\]-raclopride.	Lu AF35700 (Group 5-HT6) Lu AF35700: Cohort C1: Daily dosing with 10 mg for 21 days, Cohort C2: Daily dosing with 5 mg for 21 days, Cohort C3: Daily dosing with 5 mg for 7 days, Cohort C4: Dosing with 5 mg for 4 days (Days 1, 3, 5, and 7). 5-HT6 receptor occupancy measured using \[11C\]-Lu AE60157.
Overall Study Adverse Event	0	2	0

Baseline Characteristics

Positron Emission Tomography (PET) Study Investigating Dopamine and Serotonin Receptor Occupancy After Multiple Oral Dosing of Lu AF35700

Baseline characteristics by cohort

Measure	Lu AF35700 (Group D1) n=6 Participants Lu AF35700: Daily dosing for up to 21 days (10 mg for 21 days for Cohort A1, 10 mg for 3 days and 15 mg for 18 days for Cohort A2, and 10 mg for 3 days and 20 mg for 17 days for Cohort A3). D1 receptor occupancy measured using \[11C\]-NNC 112.	Lu AF35700 (Group D2) n=8 Participants Lu AF35700: Daily dosing for 21 days (10 mg for 3 days and 20 mg for 18 days). D2 receptor occupancy measured using \[11C\]-raclopride.	Lu AF35700 (Group 5-HT6) n=8 Participants Lu AF35700: Cohort C1: Daily dosing with 10 mg for 21 days, Cohort C2: Daily dosing with 5 mg for 21 days, Cohort C3: Daily dosing with 5 mg for 7 days, and Cohort C4: Dosing with 5 mg for 4 days (Days 1, 3, 5, and 7). 5-HT6 receptor occupancy measured using \[11C\]-Lu AE60157.	Total n=22 Participants Total of all reporting groups
Age, Continuous	41 years n=5 Participants	39 years n=7 Participants	43 years n=5 Participants	41 years n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	22 Participants n=4 Participants
Region of Enrollment United States	6 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	22 participants n=4 Participants

PRIMARY outcome

Timeframe: Change from baseline to 344 hours post last dose

Maximal target occupancy (Emax) on the D1 dopamine receptor using PET with [11C]-NNC 112 tracer compound.

The relationship between systemic exposure of Lu AF35700 and D1 dopamine occupancy was investigated using an Emax model containing the regression parameters maximal target occupancy (Emax) and plasma concentration which gives 50% of Emax (EC50). Both Emax and EC50 were estimated using one model for all post-baseline scans combined. No statistical testing was performed.

Outcome measures

Measure	Lu AF35700 (Group D1) n=6 Participants Lu AF35700: Daily dosing for up to 21 days (10 mg for 21 days for Cohort A1, 10 mg for 3 days and 15 mg for 18 days for Cohort A2, and 10 mg for 3 days and 20 mg for 17 days for Cohort A3).
Emax D1 Dopamine	81.9 percentage Interval 73.5 to 90.4

PRIMARY outcome

Timeframe: Change from baseline to 344 hours post last dose

Plasma concentration which gives 50% of Emax (EC50)

The relationship between systemic exposure of Lu AF35700 and D1 dopamine occupancy was investigated using an Emax model containing the regression parameters maximal target occupancy (Emax) and plasma concentration which gives 50% of Emax (EC50). Both Emax and EC50 were estimated using one model for all post-baseline scans combined. No statistical testing was performed.

Outcome measures

Measure	Lu AF35700 (Group D1) n=6 Participants Lu AF35700: Daily dosing for up to 21 days (10 mg for 21 days for Cohort A1, 10 mg for 3 days and 15 mg for 18 days for Cohort A2, and 10 mg for 3 days and 20 mg for 17 days for Cohort A3).
EC50 D1 Dopamine	1.4 ng/mL Interval 0.8 to 2.0

PRIMARY outcome

Timeframe: Change from baseline to 344 hours post last dose

Maximal target occupancy (Emax) on the D2 dopamine receptor using PET with [11C]-Raclopride tracer compound.

The relationship between systemic exposure of Lu AF35700 and D2 dopamine occupancy was investigated using an Emax model containing the regression parameters maximal target occupancy (Emax) and plasma concentration which gives 50% of Emax (EC50). Emax was estimated using one model for all post-baseline scans combined. No statistical testing was performed.

Outcome measures

Measure	Lu AF35700 (Group D1) n=8 Participants Lu AF35700: Daily dosing for up to 21 days (10 mg for 21 days for Cohort A1, 10 mg for 3 days and 15 mg for 18 days for Cohort A2, and 10 mg for 3 days and 20 mg for 17 days for Cohort A3).
Emax D2 Dopamine	102 percentage

PRIMARY outcome

Timeframe: Change from baseline to 344 hours post last dose

Plasma concentration which gives 50% of Emax (EC50)

The relationship between systemic exposure of Lu AF35700+Lu AF36152 and D2 dopamine occupancy was investigated using an Emax model containing the regression parameters maximal target occupancy (Emax) and plasma concentration which gives 50% of Emax (EC50). Both Emax and EC50 were estimated using one model for all post-baseline scans combined. No statistical testing was performed.

Outcome measures

Measure	Lu AF35700 (Group D1) n=8 Participants Lu AF35700: Daily dosing for up to 21 days (10 mg for 21 days for Cohort A1, 10 mg for 3 days and 15 mg for 18 days for Cohort A2, and 10 mg for 3 days and 20 mg for 17 days for Cohort A3).
EC50 D2 Dopamine	29.1 ng/mL Interval 15.9 to 42.4

PRIMARY outcome

Timeframe: Change from baseline to 344 hours post last dose

Maximal target occupancy (Emax) on the 5-HT6 receptor using PET with [11C]-Lu AE60157 as tracer compound.

The relationship between systemic exposure of Lu AF35700+Lu AF36152 and 5-HT6 occupancy was investigated using an Emax model containing the regression parameters maximal target occupancy (Emax) and plasma concentration which gives 50% of Emax (EC50). Emax was estimated using one model for all post-baseline scans combined. No statistical testing was performed.

Outcome measures

Measure	Lu AF35700 (Group D1) n=8 Participants Lu AF35700: Daily dosing for up to 21 days (10 mg for 21 days for Cohort A1, 10 mg for 3 days and 15 mg for 18 days for Cohort A2, and 10 mg for 3 days and 20 mg for 17 days for Cohort A3).
Emax 5-HT6 Serotonin	88.1 percentage Interval 84.1 to 92.1

PRIMARY outcome

Timeframe: Change from baseline to 344 hours post last dose

Plasma concentration which gives 50% of Emax (EC50)

The relationship between systemic exposure of Lu AF35700+Lu AF36152 and 5_HT6 serotonin occupancy was investigated using an Emax model containing the regression parameters maximal target occupancy (Emax) and plasma concentration which gives 50% of Emax (EC50). Both Emax and EC50 were estimated using one model for all post-baseline scans combined. No statistical testing was performed.

Outcome measures

Measure	Lu AF35700 (Group D1) n=8 Participants Lu AF35700: Daily dosing for up to 21 days (10 mg for 21 days for Cohort A1, 10 mg for 3 days and 15 mg for 18 days for Cohort A2, and 10 mg for 3 days and 20 mg for 17 days for Cohort A3).
EC50 5-HT6 Serotonin	0.4 ng/mL Interval 0.2 to 0.5

Adverse Events

Lu AF35700 (Group D1)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Lu AF35700 (Group D2)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Lu AF35700 (Group 5-HT6)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lu AF35700 (Group D1) n=6 participants at risk Lu AF35700: Daily dosing for up to 21 days (10 mg for 21 days for Cohort A1, 10 mg for 3 days and 15 mg for 18 days for Cohort A2, and 10 mg for 3 days and 20 mg for 17 days for Cohort A3). D1 receptor occupancy using \[11C\]-NNC 112	Lu AF35700 (Group D2) n=8 participants at risk Lu AF35700: Daily dosing for 21 days (10 mg for 3 days and 20 mg for 18 days). D2 receptor occupancy using \[11C\]-raclopride	Lu AF35700 (Group 5-HT6) n=8 participants at risk Lu AF35700: Cohort C1: Daily dosing with 10 mg for 21 days, Cohort C2: Daily dosing with 5 mg for 21 days, Cohort C3: Daily dosing with 5 mg for 7 days, and Cohort C4: Dosing with 5 mg for 4 days (Days 1, 3, 5, and 7). 5-HT6 (5-hydroxytryptamine-6) receptor occupancy using \[11C\]-Lu AE60157
Blood and lymphatic system disorders Chest pain	16.7% 1/6 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Psychiatric disorders Worsening of schizophrenia	0.00% 0/6 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.

Other adverse events

Measure	Lu AF35700 (Group D1) n=6 participants at risk Lu AF35700: Daily dosing for up to 21 days (10 mg for 21 days for Cohort A1, 10 mg for 3 days and 15 mg for 18 days for Cohort A2, and 10 mg for 3 days and 20 mg for 17 days for Cohort A3). D1 receptor occupancy using \[11C\]-NNC 112	Lu AF35700 (Group D2) n=8 participants at risk Lu AF35700: Daily dosing for 21 days (10 mg for 3 days and 20 mg for 18 days). D2 receptor occupancy using \[11C\]-raclopride	Lu AF35700 (Group 5-HT6) n=8 participants at risk Lu AF35700: Cohort C1: Daily dosing with 10 mg for 21 days, Cohort C2: Daily dosing with 5 mg for 21 days, Cohort C3: Daily dosing with 5 mg for 7 days, and Cohort C4: Dosing with 5 mg for 4 days (Days 1, 3, 5, and 7). 5-HT6 (5-hydroxytryptamine-6) receptor occupancy using \[11C\]-Lu AE60157
Psychiatric disorders Anxiety	33.3% 2/6 • Number of events 4 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	25.0% 2/8 • Number of events 6 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 2 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Psychiatric disorders Insomnia	16.7% 1/6 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Psychiatric disorders Psychotic Disorder	16.7% 1/6 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Nervous system disorders Headache	33.3% 2/6 • Number of events 12 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	37.5% 3/8 • Number of events 7 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	25.0% 2/8 • Number of events 2 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Ear and labyrinth disorders Tympanic Membrane Disorder	33.3% 2/6 • Number of events 2 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Ear and labyrinth disorders Ear Pain	16.7% 1/6 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Ear and labyrinth disorders Otorrhoea	16.7% 1/6 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Infections and infestations Nasopharyngitis	16.7% 1/6 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Gastrointestinal disorders Abdominal Discomfort	16.7% 1/6 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Gastrointestinal disorders Vomiting	16.7% 1/6 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Investigations Blood Urine Present	16.7% 1/6 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Investigations Weight Increased	16.7% 1/6 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	37.5% 3/8 • Number of events 3 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	25.0% 2/8 • Number of events 2 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	16.7% 1/6 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Musculoskeletal and connective tissue disorders Neck Pain	16.7% 1/6 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
General disorders Chest Pain	16.7% 1/6 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Psychiatric disorders Schizophrenia	0.00% 0/6 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Gastrointestinal disorders Tootache	0.00% 0/6 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	25.0% 2/8 • Number of events 2 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Gastrointestinal disorders Constipation	0.00% 0/6 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Investigations Aspartate aminotarnsferase increased	0.00% 0/6 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Investigations Blood lactate dehydrogenase increased	0.00% 0/6 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/6 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/6 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Investigations Gamma-glutamyl transferase increased	0.00% 0/6 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Infections and infestations Oral herpes	0.00% 0/6 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Investigations Alanine aminotransferase increased	0.00% 0/6 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Investigations Blood creatine phosphokinase increased	0.00% 0/6 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Renal and urinary disorders Pollakiuria	0.00% 0/6 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Musculoskeletal and connective tissue disorders Axillary mass	0.00% 0/6 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Eye disorders Eye irritation	0.00% 0/6 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Reproductive system and breast disorders Penis disorder	0.00% 0/6 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	12.5% 1/8 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.
Infections and infestations Rhinitis	16.7% 1/6 • Number of events 1 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.	0.00% 0/8 • Up to week 12. Adverse Events were monitored irrespective of Lu AF35700 dosing cohort, i.e., unable to know what Lu AF35700 dose event occurred at. It was pre-specified in the study to report Adverse Events by tracer group only.

Additional Information

Email contact via

H. LUndbeck A/S

Phone: +4536301311

Email: LundbeckClinicalTrials@Lundbeck.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place