Trial Outcomes & Findings for Effects of Vortioxetine (Lu AA21004) on the Concentrations of Selected Neurotransmitters in Healthy Male Adults (NCT NCT01299805)

Last Updated: 2013-12-13

Results Overview

The area under the effect-time curve from time 0 to 24 hours postdose (AUEC\[0-24\]) of the neurotransmitter 5-HT (serotonin) in plasma was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

17 participants

Primary outcome timeframe

Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.

Results posted on

2013-12-13

Participant Flow

Participants took part in the study at one investigative site in the United States from 14 March 2011 to 11 June 2011.

In this study, 17 healthy men were enrolled and randomized to receive an oral dose of vortioxetine 20 mg or placebo in a 2:1 ratio.

Participant milestones

Participant milestones
Measure	Vortioxetine Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.	Placebo Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
Overall Study STARTED	12	5
Overall Study COMPLETED	10	5
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Vortioxetine Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.	Placebo Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
Overall Study Adverse Event	2	0

Baseline Characteristics

Effects of Vortioxetine (Lu AA21004) on the Concentrations of Selected Neurotransmitters in Healthy Male Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vortioxetine n=12 Participants Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.	Placebo n=5 Participants Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.	Total n=17 Participants Total of all reporting groups
Age Continuous	34.3 years STANDARD_DEVIATION 11.19 • n=5 Participants	34.8 years STANDARD_DEVIATION 10.71 • n=7 Participants	34.4 years STANDARD_DEVIATION 10.71 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	9 participants n=5 Participants	5 participants n=7 Participants	14 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized White	9 participants n=5 Participants	4 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	5 participants n=7 Participants	17 participants n=5 Participants
Height	176.8 cm STANDARD_DEVIATION 5.88 • n=5 Participants	175.9 cm STANDARD_DEVIATION 8.15 • n=7 Participants	176.6 cm STANDARD_DEVIATION 6.37 • n=5 Participants
Weight	81.8 kg STANDARD_DEVIATION 8.84 • n=5 Participants	79.9 kg STANDARD_DEVIATION 7.52 • n=7 Participants	81.3 kg STANDARD_DEVIATION 8.29 • n=5 Participants
Body Mass Index (BMI)	26.2 kg/m^2 STANDARD_DEVIATION 2.85 • n=5 Participants	25.8 kg/m^2 STANDARD_DEVIATION 1.92 • n=7 Participants	26.1 kg/m^2 STANDARD_DEVIATION 2.56 • n=5 Participants
Current nicotine user Yes	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Current nicotine user No	12 participants n=5 Participants	5 participants n=7 Participants	17 participants n=5 Participants
Former nicotine user Yes	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Former nicotine user No	11 participants n=5 Participants	4 participants n=7 Participants	15 participants n=5 Participants
Drinking habits Drinks 0-14/week	12 participants n=5 Participants	5 participants n=7 Participants	17 participants n=5 Participants
Drinking habits Drinks >14/week	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Caffeine consumption Consumes 0-5 cups daily	12 participants n=5 Participants	5 participants n=7 Participants	17 participants n=5 Participants
Caffeine consumption Consumes >5 cups daily	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants

PRIMARY outcome

Timeframe: Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.

Population: The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. "n" indicates the number of patients with available data at each time point.

Outcome measures

Outcome measures
Measure	Vortioxetine n=12 Participants Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.	Placebo n=5 Participants Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxytryptamine (5-HT) in Plasma Day -1 (n=10, 4)	4183024 pg*hr/mL Standard Deviation 1362135	3854399 pg*hr/mL Standard Deviation 1728230
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxytryptamine (5-HT) in Plasma Day 1 (n=6, 4)	4224058 pg*hr/mL Standard Deviation 2028835	3912292 pg*hr/mL Standard Deviation 2083773
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxytryptamine (5-HT) in Plasma Day 14 (n=9, 5)	1718863 pg*hr/mL Standard Deviation 530633	3858350 pg*hr/mL Standard Deviation 2212719

PRIMARY outcome

Timeframe: Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.

The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HT in plasma measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).

Outcome measures

Outcome measures
Measure	Vortioxetine n=12 Participants Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.	Placebo n=5 Participants Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
Maximum Concentration of 5-HT in Plasma Day 14 (n=9, 5)	94233.3 pg/mL Standard Deviation 40258.4	242200 pg/mL Standard Deviation 115103
Maximum Concentration of 5-HT in Plasma Day -1 (n=10, 4)	273800 pg/mL Standard Deviation 111197	231500 pg/mL Standard Deviation 98083.3
Maximum Concentration of 5-HT in Plasma Day 1 (n=6, 4)	247667 pg/mL Standard Deviation 136695	251250 pg/mL Standard Deviation 63615.4

PRIMARY outcome

Timeframe: Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.

The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-HT in plasma at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).

Outcome measures

Outcome measures
Measure	Vortioxetine n=12 Participants Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.	Placebo n=5 Participants Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
Time to Maximum Concentration of 5-HT in Plasma Day -1 (n=10, 4)	12.65 hours Standard Deviation 9.409	7.26 hours Standard Deviation 7.984
Time to Maximum Concentration of 5-HT in Plasma Day 1 (n=6, 4)	4.86 hours Standard Deviation 7.253	14.42 hours Standard Deviation 11.146
Time to Maximum Concentration of 5-HT in Plasma Day 14 (n=9, 5)	9.11 hours Standard Deviation 10.080	8.40 hours Standard Deviation 6.986

PRIMARY outcome

Timeframe: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.

The area under the effect-time curve from time 0 to 24 hours postdose (AUEC\[0-24\]) of 5-hydroxytryptamine (5-HT) in cerebrospinal fluid (CSF) was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).

Outcome measures

Outcome measures
Measure	Vortioxetine n=12 Participants Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.	Placebo n=5 Participants Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HT in Cerebrospinal Fluid Day -1 (n=11, 5)	987.71 pg*hr/mL Standard Deviation 1898.943	509.77 pg*hr/mL Standard Deviation 199.658
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HT in Cerebrospinal Fluid Day 14 (n=9, 5)	1165.73 pg*hr/mL Standard Deviation 290.389	444.88 pg*hr/mL Standard Deviation 24.908
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HT in Cerebrospinal Fluid Day 1 (n=11, 5)	627.78 pg*hr/mL Standard Deviation 164.679	497.40 pg*hr/mL Standard Deviation 302.720

PRIMARY outcome

Timeframe: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.

The maximum observed effect (Emax), assessed by the maximum concentration of 5-HT in cerebrospinal fluid (CSF) measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).

Outcome measures

Outcome measures
Measure	Vortioxetine n=12 Participants Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.	Placebo n=5 Participants Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
Maximum Concentration of 5-HT in Cerobrospinal Fluid Day -1 (n=11, 5)	116.60 pg/mL Standard Deviation 293.721	67.74 pg/mL Standard Deviation 94.396
Maximum Concentration of 5-HT in Cerobrospinal Fluid Day 1 (n=11, 5)	35.46 pg/mL Standard Deviation 13.172	24.10 pg/mL Standard Deviation 14.030
Maximum Concentration of 5-HT in Cerobrospinal Fluid Day 14 (n=9, 5)	59.80 pg/mL Standard Deviation 16.524	51.46 pg/mL Standard Deviation 33.647

PRIMARY outcome

Timeframe: Day -1, Day 1 and Day 14. CSF samples were taken predose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.

The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-HT in cerebrospinal fluid (CSF) at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).

Outcome measures

Outcome measures
Measure	Vortioxetine n=12 Participants Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.	Placebo n=5 Participants Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
Time to Maximum Concentration of 5-HT in Cerebrospinal Fluid Day -1 (n=11, 5)	4.30 hours Standard Deviation 5.890	7.13 hours Standard Deviation 10.624
Time to Maximum Concentration of 5-HT in Cerebrospinal Fluid Day 1 (n=11, 5)	17.32 hours Standard Deviation 7.177	6.92 hours Standard Deviation 8.225
Time to Maximum Concentration of 5-HT in Cerebrospinal Fluid Day 14 (n=9, 5)	3.02 hours Standard Deviation 3.576	4.94 hours Standard Deviation 6.964

PRIMARY outcome

Timeframe: Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.

Area under the effect-time curve from time 0 to 24 hours postdose (AUEC\[0-24\]) of 5-HIAA, a metabolite of the neurotransmitter serotonin, in plasma was measured after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1.

Outcome measures

Outcome measures
Measure	Vortioxetine n=12 Participants Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.	Placebo n=5 Participants Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxyindoleacetic Acid (5-HIAA) in Plasma Day 1 (n=12, 5)	140.01 ng*hr/mL Standard Deviation 23.633	145.92 ng*hr/mL Standard Deviation 28.844
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxyindoleacetic Acid (5-HIAA) in Plasma Day 14 (n=10, 5)	143.69 ng*hr/mL Standard Deviation 30.049	140.40 ng*hr/mL Standard Deviation 25.305

PRIMARY outcome

Timeframe: Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.

The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HIAA in plasma measured after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1

Outcome measures

Outcome measures
Measure	Vortioxetine n=12 Participants Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.	Placebo n=5 Participants Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
Maximum Concentration of 5-HIAA in Plasma Day 1 (n=12, 5)	7.25 ng/mL Standard Deviation 1.113	6.97 ng/mL Standard Deviation 1.282
Maximum Concentration of 5-HIAA in Plasma Day 14 (n=10, 5)	6.90 ng/mL Standard Deviation 1.402	7.10 ng/mL Standard Deviation 1.301

PRIMARY outcome

Timeframe: Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.

The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-hydroxyindoleacetic acid (5-HIAA) in plasma after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1.

Outcome measures

Outcome measures
Measure	Vortioxetine n=12 Participants Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.	Placebo n=5 Participants Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
Time to Maximum Concentration of 5-HIAA in Plasma Day 1 (n=12, 5)	13.02 hours Standard Deviation 10.992	15.13 hours Standard Deviation 9.886
Time to Maximum Concentration of 5-HIAA in Plasma Day 14 (n=10, 5)	16.80 hours Standard Deviation 7.005	18.40 hours Standard Deviation 5.367

PRIMARY outcome

Timeframe: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.

The area under the effect-time curve from time 0 to 24 hours postdose (AUEC\[0-24\]) of 5-hydroxyindoleacetic acid (5-HIAA) in cerebrospinal fluid (CSF) was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).

Outcome measures

Outcome measures
Measure	Vortioxetine n=12 Participants Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.	Placebo n=5 Participants Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HIAA in Cerebrospinal Fluid Day -1 (n=12, 5)	620.61 ng*hr/mL Standard Deviation 182.391	718.14 ng*hr/mL Standard Deviation 247.082
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HIAA in Cerebrospinal Fluid Day 1 (n=12, 5)	636.14 ng*hr/mL Standard Deviation 246.071	774.95 ng*hr/mL Standard Deviation 319.860
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HIAA in Cerebrospinal Fluid Day 14 (n=9, 5)	429.23 ng*hr/mL Standard Deviation 99.575	644.24 ng*hr/mL Standard Deviation 206.121

PRIMARY outcome

Timeframe: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.

The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HIAA in cerebrospinal fluid (CSF) measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).

Outcome measures

Outcome measures
Measure	Vortioxetine n=12 Participants Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.	Placebo n=5 Participants Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
Maximum Concentration of 5-HIAA in Cerebrospinal Fluid Day -1 (n=12, 5)	29.87 ng/mL Standard Deviation 8.231	34.30 ng/mL Standard Deviation 12.270
Maximum Concentration of 5-HIAA in Cerebrospinal Fluid Day 1 (n=12, 5)	31.13 ng/mL Standard Deviation 9.567	36.98 ng/mL Standard Deviation 18.346
Maximum Concentration of 5-HIAA in Cerebrospinal Fluid Day 14 (n=9, 5)	20.18 ng/mL Standard Deviation 4.935	30.16 ng/mL Standard Deviation 8.768

PRIMARY outcome

Timeframe: Day -1, Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.

The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-hydroxyindoleacetic acid (5-HIAA) in cerebrospinal fluid (CSF) at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).

Outcome measures

Outcome measures
Measure	Vortioxetine n=12 Participants Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.	Placebo n=5 Participants Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
Time to Maximum Concentration of 5-HIAA in Cerebrospinal Fluid Day 1 (n=12, 5)	6.24 hours Standard Deviation 8.960	19.00 hours Standard Deviation 10.621
Time to Maximum Concentration of 5-HIAA in Cerebrospinal Fluid Day -1 (n=12, 5)	14.16 hours Standard Deviation 10.710	19.78 hours Standard Deviation 8.877
Time to Maximum Concentration of 5-HIAA in Cerebrospinal Fluid Day 14 (n=9, 5)	11.70 hours Standard Deviation 10.576	9.90 hours Standard Deviation 9.592

Adverse Events

Vortioxetine

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vortioxetine n=12 participants at risk Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.	Placebo n=5 participants at risk Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
Gastrointestinal disorders Nausea	41.7% 5/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Vomiting	33.3% 4/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Chest discomfort	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Tenderness	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Post lumbar puncture syndrome	50.0% 6/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	40.0% 2/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Back pain	50.0% 6/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	20.0% 1/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	33.3% 4/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	20.0% 1/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dizziness	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Paraesthesia	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Tension headache	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director, Clinical Science

Takeda

Phone: 800-778-2860

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights therefrom or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
Publication restrictions are in place

Restriction type: OTHER