Trial Outcomes & Findings for A Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants (NCT NCT03949621)

NCT ID: NCT03949621

Last Updated: 2019-11-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 24 participants
• Primary outcome timeframe: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
• Results posted on: 2019-11-13

Participant Flow

Participants took part in the study at 1 investigative site in the United States from 06 February 2018 to 13 August 2018.

Healthy participants were enrolled in one of the two device presentation groups to receive vedolizumab subcutaneous (SC) 108 milligram (mg) using prefilled syringe (PFS) or using an investigational device. Primary objective was to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).

Participant milestones

Measure	Group A: Vedolizumab SC PFS Vedolizumab SC 108 mg, injection, subcutaneously using PFS, once on Day 1.	Group B: Vedolizumab SC Investigational Device Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants

Baseline characteristics by cohort

Measure	Group A: Vedolizumab SC PFS n=12 Participants Vedolizumab SC 108 mg, injection, subcutaneously using PFS, once on Day 1.	Group B: Vedolizumab SC Investigational Device n=12 Participants Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.	Total n=24 Participants Total of all reporting groups
Age, Continuous	37.8 years STANDARD_DEVIATION 12.93 • n=5 Participants	46.0 years STANDARD_DEVIATION 9.95 • n=7 Participants	41.9 years STANDARD_DEVIATION 12.03 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Weight	70.98 kilogram (Kg) STANDARD_DEVIATION 11.526 • n=5 Participants	69.45 kilogram (Kg) STANDARD_DEVIATION 8.158 • n=7 Participants	70.22 kilogram (Kg) STANDARD_DEVIATION 9.797 • n=5 Participants
Height	166.8 centimeter (cm) STANDARD_DEVIATION 10.81 • n=5 Participants	167.5 centimeter (cm) STANDARD_DEVIATION 5.93 • n=7 Participants	167.2 centimeter (cm) STANDARD_DEVIATION 8.53 • n=5 Participants
Body mass index (BMI)	25.408 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.2550 • n=5 Participants	24.685 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.2687 • n=7 Participants	25.047 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.2428 • n=5 Participants

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose

Population: The pharmacokinetic (PK) set included all participants who received study drug and had at least one measurable serum concentration.

Outcome measures

Measure	Group A: Vedolizumab SC PFS n=12 Participants Vedolizumab SC 108 mg, injection, subcutaneously using PFS, once on Day 1.	Group B: Vedolizumab SC Investigational Device n=12 Participants Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC	493.5 microgram*day per milliliter(mcg*day/mL) Geometric Coefficient of Variation 34.9	485.8 microgram*day per milliliter(mcg*day/mL) Geometric Coefficient of Variation 23.7

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose

Population: The PK set included all participants who received study drug and had at least one measurable serum concentration.

Outcome measures

Measure	Group A: Vedolizumab SC PFS n=12 Participants Vedolizumab SC 108 mg, injection, subcutaneously using PFS, once on Day 1.	Group B: Vedolizumab SC Investigational Device n=12 Participants Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC	515.2 mcg*day/mL Geometric Coefficient of Variation 34.1	505.4 mcg*day/mL Geometric Coefficient of Variation 21.7

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose

Population: The PK set included all participants who received study drug and had at least one measurable serum concentration.

Outcome measures

Measure	Group A: Vedolizumab SC PFS n=12 Participants Vedolizumab SC 108 mg, injection, subcutaneously using PFS, once on Day 1.	Group B: Vedolizumab SC Investigational Device n=12 Participants Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
Cmax: Maximum Observed Serum Concentration for Vedolizumab SC	16.46 microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 21.4	16.99 microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 17.2

Adverse Events

Group A: Vedolizumab SC PFS

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Group B: Vedolizumab SC Investigational Device

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group A: Vedolizumab SC PFS n=12 participants at risk Vedolizumab SC 108 mg, injection, subcutaneously using PFS, once on Day 1.	Group B: Vedolizumab SC Investigational Device n=12 participants at risk Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. 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 Tibia fracture	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Measure	Group A: Vedolizumab SC PFS n=12 participants at risk Vedolizumab SC 108 mg, injection, subcutaneously using PFS, once on Day 1.	Group B: Vedolizumab SC Investigational Device n=12 participants at risk Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
Eye disorders Cataract	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Conjunctival cyst	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Dry eye	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Retinal drusen	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Constipation	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Flatulence	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Nausea	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Feeling hot	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Injection site erythema	16.7% 2/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Injection site induration	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Injection site pain	41.7% 5/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	41.7% 5/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Rhinitis	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 3/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Viral infection	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. 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 Dental restoration failure	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. 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 Sunburn	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Weight increased	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. 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 Muscle spasms	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. 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 the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. 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 Pain in extremity	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. 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	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. 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	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Somnolence	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Insomnia	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. 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

Takeda

Phone: +1-877-825-3327

Email: trialdisclosures@takeda.com

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 from 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