NCT03870555

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and PK of single ascending intravenous doses of TAK-954.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Mar 2019

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

March 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 24, 2020

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

March 4, 2019

Results QC Date

May 5, 2020

Last Update Submit

June 11, 2020

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (16)

  • Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) for TAK-954

    Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)

  • Number of Participants With Clinically Significant Change From Baseline in Vital Signs for TAK-954

    Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)

  • Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) for TAK-954

    Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)

  • Number of Participants With Clinically Notable Shifts From Baseline to Abnormal Post-dose in Clinical Laboratory Values for TAK-954

    Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)

  • AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954

    Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose

  • AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954

    Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose

  • Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-954

    Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose

  • CL: Total Clearance After Intravenous Administration for TAK-954

    Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose

  • Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-954

    Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose

  • Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 12 Hours Post-dose

    Day 2 pre-dose and at multiple time points (up to 12 hours) post-dose

  • Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 24 Hours Post-dose

    Day 2 pre-dose and at multiple time points (up to 24 hours) post-dose

  • Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 36 Hours Post-dose

    Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose

  • Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 12 Hours Post-dose

    Day 2 pre-dose and at multiple time points (up to 12 hours) post-dose

  • Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 24 Hours Post-dose

    Day 2 pre-dose and at multiple time points (up to 24 hours) post-dose

  • Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 36 Hours Post-dose

    Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose

  • CLR: Renal Clearance for TAK-954

    Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose

Secondary Outcomes (3)

  • Number of Participants With First Stool of TAK-954 Within 36 Hours Post-dose on Day 2

    Day 2 dosing and at multiple time points (up to 36 hours) post-dose

  • Mean Number of Stools of TAK-954 Within 36 Hours Post-dose on Day 2

    Day 2 dosing and at multiple time points (up to 36 hours) post-dose

  • Instances of Stool Type of TAK-954 Based on Bristol Stool Form Scale

    Day 2 dosing and at multiple time points (up to 36 hours) post-dose

Study Arms (3)

Sequence 1

EXPERIMENTAL

Period 1: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2. Period 2: TAK-954 0.1 milligram (mg), infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 1 mg infusion, administered intravenously over 60-minutes, once on Day 2. Period 3: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 2 mg infusion, administered intravenously over 60-minutes, once on Day 2. A washout period of at least 16 days will be maintained between each Treatment Period.

Drug: TAK-954Drug: TAK-954 Placebo

Sequence 2

EXPERIMENTAL

Period 1: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 0.5 mg infusion, administered intravenously over 60-minutes once on Day 2. Period 2: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2. Period 3: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 2 mg, infusion, administered intravenously over 60-minutes, once on Day 2. A washout period of at least 16 days will be maintained between each Treatment Period.

Drug: TAK-954Drug: TAK-954 Placebo

Sequence 3

EXPERIMENTAL

Period 1: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 0.5 mg, infusion, administered intravenously over 60-minutes once on Day 2. Period 2: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 1 mg, infusion, administered intravenously over 60-minutes, once on Day 2. Period 3: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2. A washout period of at least 16 days will be maintained between each Treatment Period.

Drug: TAK-954Drug: TAK-954 Placebo

Interventions

TAK-954DRUG

TAK-954 infusion administered intravenously.

Sequence 1Sequence 2Sequence 3
TAK-954 PlaceboDRUG

TAK-954 placebo-matching infusion intravenous.

Sequence 1Sequence 2Sequence 3

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) greater than or equal to (\>=) 18 and less than or equal to (\<=) 32 kilogram per square meter (kg/m\^2), weighing \>=50 kilogram (kg) at screening.
  • Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, orthostatic vital signs, or ECGs, as deemed by the Investigator or designee.
  • Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dose and throughout the study, based on participant self-reporting.

You may not qualify if:

  • History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
  • Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing.
  • Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 2 weeks of first dosing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Results Point of Contact

Title
Medical Director
Organization
Takeda
trialdisclosures@takeda.com
+1-877-825-3327

Study Officials

  • Medical Director

    Millennium Pharmaceuticals, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 12, 2019

Study Start

March 8, 2019

Primary Completion

May 16, 2019

Study Completion

May 16, 2019

Last Updated

June 24, 2020

Results First Posted

June 24, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Locations

US(1)