Skip to main content
OpenTrials
Completed

NCT Number: NCT03870555

A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-954 in Healthy Adult Participants

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

About this study

The drug being tested in this study is called TAK-954. This study will assess the safety, tolerability, PK and PD of single ascending TAK-954 higher intravenous doses than those previously studied.

The study will enroll approximately 6 participants. Participants will be randomly assigned (By chance, like flipping a coin) to one of the three treatment sequences-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).

In each treatment sequence, each participant will receive 2 doses of active drug out of 3 dose levels (TAK-954 0.5 mg, TAK-954 1 mg, or TAK-954 2 mg) and 1 dose of Placebo. Dose escalation will be based on the available safety/tolerability data from the previous period.

This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 73 days. Participants will make a final visit on Day 16 after receiving their last dose of study drug for a follow-up assessment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

TAK-954

Drug

TAK-954 infusion administered intravenously.

TAK-954 Placebo

Drug

TAK-954 placebo-matching infusion intravenous.

Primary outcomes

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

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

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

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

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

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

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

  8. CL: Total Clearance After Intravenous Administration for TAK-954

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  16. CLR: Renal Clearance for TAK-954

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

Secondary outcomes

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

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

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

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

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

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

    Number of occurrences for each stool type was reported based on their type assessed from Bristol Stool form scale. The Bristol Stool Form Scale was used to assess the stool shape using a 7-point scale. Where, Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipation and a score of 6 or 7 indicates diarrhea.

Sponsors and collaborators

Lead sponsor

Millennium Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, 3-Period, Incomplete Block Design Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-954 in Healthy Adult Participants

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 12, 2019
Registry last updated
Jun 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.