Phase 1 Completed N=6 Randomized Double-blind Other

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

Healthy Volunteers

Source: ClinicalTrials.gov NCT03870555 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2020

Primary outcomePrimary: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) for TAK-954 — 4; 3; 0 Participants

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) for TAK-954	4; 3; 0	—
PRIMARY Number of Participants With Clinically Significant Change From Baseline in Vital Signs for TAK-954	0; 0; 0	—
PRIMARY Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) for TAK-954	0; 0; 0	—
PRIMARY Number of Participants With Clinically Notable Shifts From Baseline to Abnormal Post-dose in Clinical Laboratory Values for TAK-954	0; 0; 0	—
PRIMARY AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954	88930; 163200; 298400	—
PRIMARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954	89220; 163700; 299500	—
PRIMARY Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-954	7502; 15260; 30270	—
PRIMARY CL: Total Clearance After Intravenous Administration for TAK-954	5.604; 6.110; 6.679	—
PRIMARY Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-954	197.9; 387.7; 901.7	—
PRIMARY Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 12 Hours Post-dose	104300; 226000; 408900	—
PRIMARY Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 24 Hours Post-dose	53200; 115300; 190700	—
PRIMARY Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 36 Hours Post-dose	32420; 66560; 103600	—
PRIMARY Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 12 Hours Post-dose	20.86; 22.60; 20.45	—
PRIMARY Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 24 Hours Post-dose	10.64; 11.53; 9.534	—
PRIMARY Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 36 Hours Post-dose	6.484; 6.656; 5.181	—
PRIMARY CLR: Renal Clearance for TAK-954	3.457; 3.933; 3.624	—
SECONDARY Number of Participants With First Stool of TAK-954 Within 36 Hours Post-dose on Day 2	3; 4; 3	—
SECONDARY Mean Number of Stools of TAK-954 Within 36 Hours Post-dose on Day 2	3.3; 2.0; 1.0	—
SECONDARY Instances of Stool Type of TAK-954 Based on Bristol Stool Form Scale	0; 0; 0; 2; 3; 2	—

Eligibility Criteria

Inclusion Criteria

Body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to ( =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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03870555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.