Trial Outcomes & Findings for A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants (NCT NCT03329209)

NCT ID: NCT03329209

Last Updated: 2019-09-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 16 participants
• Primary outcome timeframe: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
• Results posted on: 2019-09-06

Participant Flow

Participants took part in the study at 1 investigative site in China from 05 March 2018 to 05 September 2018.

Healthy Chinese participants were enrolled to receive a single dose of vedolizumab intravenous 300 milligram (mg).

Participant milestones

Measure	Vedolizumab 300 mg Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants

Baseline characteristics by cohort

Measure	Vedolizumab 300 mg n=16 Participants Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1.
Age, Continuous	30.4 years STANDARD_DEVIATION 6.22 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	16 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment China	16 Participants n=5 Participants
Height	167.00 centimeter (cm) STANDARD_DEVIATION 7.474 • n=5 Participants
Weight	63.83 kilogram (kg) STANDARD_DEVIATION 6.448 • n=5 Participants
Body Mass Index (BMI)	22.87 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.622 • 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) analysis set consisted of all participants who received study drug and had at least 1 measurable serum concentration.

Outcome measures

Measure	Vedolizumab 300 mg n=16 Participants Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1.
Cmax: Maximum Observed Serum Concentration for Vedolizumab	136.4120 microgram per milliliter (mcg/mL) Standard Deviation 15.90597

PRIMARY outcome

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

Population: The PK analysis set consisted of all participants who received study drug and had at least 1 measurable serum concentration.

Outcome measures

Measure	Vedolizumab 300 mg n=16 Participants Vedolizumab 300 mg, infusion, intravenously over 30-minutes, 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	2342.5803 day*microgram per milliliter(day*mcg/mL) Standard Deviation 294.75822

PRIMARY outcome

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

Population: The PK analysis set consisted of all participants who received study drug and had at least 1 measurable serum concentration.

Outcome measures

Measure	Vedolizumab 300 mg n=16 Participants Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1.
AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab	2377.6463 day*mcg/mL Standard Deviation 296.46345

SECONDARY outcome

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

Population: The safety analysis set consisted of all participants who were enrolled and received 1 dose of study drug.

Outcome measures

Measure	Vedolizumab 300 mg n=16 Participants Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1.
Percentage of Participants With Positive Anti-vedolizumab Antibody (AVA)	37.5 percentage of participants

SECONDARY outcome

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

Population: The safety analysis set consisted of all participants who were enrolled and received 1 dose of study drug.

Outcome measures

Measure	Vedolizumab 300 mg n=16 Participants Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1.
Percentage of Participants With Positive Neutralizing AVA	37.5 percentage of participants

Adverse Events

Vedolizumab 300 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Vedolizumab 300 mg n=16 participants at risk Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1.
Infections and infestations Upper respiratory tract infection	25.0% 4/16 • Treatment emergent adverse events (TEAE) are adverse events that started after the infusion of study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AES 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 Blood creatine phosphokinase increased	6.2% 1/16 • Treatment emergent adverse events (TEAE) are adverse events that started after the infusion of study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AES 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 Hepatic enzyme increased	6.2% 1/16 • Treatment emergent adverse events (TEAE) are adverse events that started after the infusion of study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AES 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.
Renal and urinary disorders Leukocyturia	12.5% 2/16 • Treatment emergent adverse events (TEAE) are adverse events that started after the infusion of study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AES 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