CompletedNCT03870555Updated Jun 24, 2020Results posted

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

A Phase 1 interventional study of TAK-954 and TAK-954 Placebo in Healthy Volunteers, sponsored by Millennium Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-24.

Sponsored by Millennium Pharmaceuticals, Inc. · Phase 1, Interventional, and Other

Phase: Phase 1
Study type: Interventional
Enrollment: 6
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

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

Read the detailed description

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.

Conditions studied

Healthy Volunteers

Keywords

Drug Therapy

In context

Lead sponsor

Millennium Pharmaceuticals, Inc. is the lead sponsor of 173 studies on the registry; none are open to participants now.

Of its 73 completed or terminated interventional studies of FDA-regulated products, 72 (99%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 6 participants (actual)

Study arms

Experimental
Sequence 1
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-954 · Drug: TAK-954 Placebo
Experimental
Sequence 2
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-954 · Drug: TAK-954 Placebo
Experimental
Sequence 3
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-954 · Drug: TAK-954 Placebo

Interventions

DrugTAK-954
TAK-954 infusion administered intravenously.
DrugTAK-954 Placebo
TAK-954 placebo-matching infusion intravenous.

What researchers measure

Primary outcomes

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)
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)
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)
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)
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
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
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
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
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
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
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
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
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
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
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
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

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
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
Instances of Stool Type of TAK-954 Based on Bristol Stool Form Scale
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.
Time frame: Day 2 dosing and at multiple time points (up to 36 hours) post-dose

Results

Posted Jun 24, 2020

Participant flow

Participants took part in the study at 1 investigative site in the United States from 08 March 2019 to 16 May 2019.

Period 1 (2 Days)

Participant flow — Period 1 (2 Days)
Milestone	Sequence 1: Placebo + TAK-954 1 mg + TAK-954 2 mg	Sequence 2: TAK-954 0.5 mg + Placebo + TAK-954 2 mg	Sequence 3: TAK-954 0.5 mg + TAK-954 1 mg + Placebo
Started	2	2	2
Completed	2	2	2
Not completed	0	0	0

Washout Period (at Least 16 Days)

Participant flow — Washout Period (at Least 16 Days)
Milestone	Sequence 1: Placebo + TAK-954 1 mg + TAK-954 2 mg	Sequence 2: TAK-954 0.5 mg + Placebo + TAK-954 2 mg	Sequence 3: TAK-954 0.5 mg + TAK-954 1 mg + Placebo
Started	2	2	2
Completed	2	2	2
Not completed	0	0	0

Period 2 (2 Days)

Participant flow — Period 2 (2 Days)
Milestone	Sequence 1: Placebo + TAK-954 1 mg + TAK-954 2 mg	Sequence 2: TAK-954 0.5 mg + Placebo + TAK-954 2 mg	Sequence 3: TAK-954 0.5 mg + TAK-954 1 mg + Placebo
Started	2	2	2
Completed	2	2	2
Not completed	0	0	0

Washout Period (at Least 16 Days)

Participant flow — Washout Period (at Least 16 Days)
Milestone	Sequence 1: Placebo + TAK-954 1 mg + TAK-954 2 mg	Sequence 2: TAK-954 0.5 mg + Placebo + TAK-954 2 mg	Sequence 3: TAK-954 0.5 mg + TAK-954 1 mg + Placebo
Started	2	2	2
Completed	2	2	2
Not completed	0	0	0

Period 3 (2 Days)

Participant flow — Period 3 (2 Days)
Milestone	Sequence 1: Placebo + TAK-954 1 mg + TAK-954 2 mg	Sequence 2: TAK-954 0.5 mg + Placebo + TAK-954 2 mg	Sequence 3: TAK-954 0.5 mg + TAK-954 1 mg + Placebo
Started	2	2	2
Completed	1	2	2
Not completed	1	0	0
Withdrew: Adverse event	1	0	0

Outcome measures

PrimaryNumber 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)
Reported as:: Count of participants · Participants

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) for TAK-954
Participants	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) for TAK-954	4	3	0

PrimaryNumber 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)
Reported as:: Count of participants · Participants

Number of Participants With Clinically Significant Change From Baseline in Vital Signs for TAK-954
Participants	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg
Number of Participants With Clinically Significant Change From Baseline in Vital Signs for TAK-954	0	0	0

PrimaryNumber 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)
Reported as:: Count of participants · Participants

Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) for TAK-954
Participants	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) for TAK-954	0	0	0

PrimaryNumber 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)
Reported as:: Count of participants · Participants

Number of Participants With Clinically Notable Shifts From Baseline to Abnormal Post-dose in Clinical Laboratory Values for TAK-954
Participants	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg
Number of Participants With Clinically Notable Shifts From Baseline to Abnormal Post-dose in Clinical Laboratory Values for TAK-954	0	0	0

PrimaryAUClast: 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
Reported as:: Geometric mean · picogram*hour per milliliter (pg*hr/mL)

AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954
picogramhour per milliliter (pghr/mL)	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954	88930 ± 23.0	163200 ± 12.8	298400 ± 29.6

PrimaryAUC∞: 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
Reported as:: Geometric mean · pg*hr/mL

AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954
pg*hr/mL	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954	89220 ± 22.8	163700 ± 12.8	299500 ± 29.6

PrimaryCeoi: 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
Reported as:: Geometric mean · picogram per milliliter (pg/mL)

Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-954
picogram per milliliter (pg/mL)	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg
Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-954	7502 ± 24.1	15260 ± 12.9	30270 ± 28.5

PrimaryCL: 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
Reported as:: Geometric mean · liter per hour (L/hr)

CL: Total Clearance After Intravenous Administration for TAK-954
liter per hour (L/hr)	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg
CL: Total Clearance After Intravenous Administration for TAK-954	5.604 ± 22.8	6.110 ± 12.8	6.679 ± 29.6

PrimaryVz: 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
Reported as:: Geometric mean · liter

Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-954
liter	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg
Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-954	197.9 ± 13.7	387.7 ± 45.6	901.7 ± 61.7

PrimaryAe: 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
Reported as:: Geometric mean · nanogram

Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 12 Hours Post-dose
nanogram	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg
Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 12 Hours Post-dose	104300 ± 6.3	226000 ± 16.0	408900 ± 15.3

PrimaryAe: 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
Reported as:: Geometric mean · nanogram

Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 24 Hours Post-dose
nanogram	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg
Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 24 Hours Post-dose	53200 ± 27.3	115300 ± 19.9	190700 ± 23.7

PrimaryAe: 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
Reported as:: Geometric mean · nanogram

Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 36 Hours Post-dose
nanogram	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg
Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 36 Hours Post-dose	32420 ± 17.3	66560 ± 5.3	103600 ± 8.5

PrimaryFe: 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
Reported as:: Geometric mean · percentage

Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 12 Hours Post-dose
percentage	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg
Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 12 Hours Post-dose	20.86 ± 6.3	22.60 ± 16.0	20.45 ± 15.3

PrimaryFe: 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
Reported as:: Geometric mean · percentage

Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 24 Hours Post-dose
percentage	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg
Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 24 Hours Post-dose	10.64 ± 27.3	11.53 ± 19.9	9.534 ± 23.7

PrimaryFe: 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
Reported as:: Geometric mean · percentage

Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 36 Hours Post-dose
percentage	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg
Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 36 Hours Post-dose	6.484 ± 17.3	6.656 ± 5.3	5.181 ± 8.5

PrimaryCLR: Renal Clearance for TAK-954

Time frame:: Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose
Reported as:: Geometric mean · L/hr

CLR: Renal Clearance for TAK-954
L/hr	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg
CLR: Renal Clearance for TAK-954	3.457 ± 19.9	3.933 ± 8.9	3.624 ± 35.0

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With First Stool of TAK-954 Within 36 Hours Post-dose on Day 2
Participants	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg
Number of Participants With First Stool of TAK-954 Within 36 Hours Post-dose on Day 2	3	4	3

SecondaryMean 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
Reported as:: Mean · stools

Mean Number of Stools of TAK-954 Within 36 Hours Post-dose on Day 2
stools	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg
Mean Number of Stools of TAK-954 Within 36 Hours Post-dose on Day 2	3.3 ± 3.40	2.0 ± 0.82	1.0 ± 0.00

SecondaryInstances of Stool Type of TAK-954 Based on Bristol Stool Form Scale

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.

Time frame:: Day 2 dosing and at multiple time points (up to 36 hours) post-dose
Reported as:: Number · number of occurrences

Instances of Stool Type of TAK-954 Based on Bristol Stool Form Scale
number of occurrences	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg
Type 1	0	0	0
Type 2	2	3	2
Type 3	0	1	0
Type 4	1	2	1
Type 5	3	1	0
Type 6	5	1	0
Type 7	2	0	0

Adverse events

Collected over Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: 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). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Lead-in Dose: TAK-954 0.1 mg	0/6 (0%)	0/6 (0%)	5/6 (83.3%)
Lead-in Dose: Placebo	0/6 (0%)	0/6 (0%)	1/6 (16.7%)
Treatment Dose: TAK-954 0.5 mg	0/4 (0%)	0/4 (0%)	4/4 (100%)
Treatment Dose: TAK-954 1 mg	0/4 (0%)	0/4 (0%)	3/4 (75%)
Treatment Dose: TAK-954 2 mg	0/3 (0%)	0/3 (0%)	0/3 (0%)
Treatment Dose: Placebo	0/6 (0%)	0/6 (0%)	0/6 (0%)

Most frequent other events

Showing 10 of 20

Most frequent other events
Event	Lead-in Dose: TAK-954 0.1 mg	Lead-in Dose: Placebo	Treatment Dose: TAK-954 0.5 mg	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg	Treatment Dose: Placebo
NauseaGastrointestinal disorders	4/6	0/6	2/4	1/4	0/3	0/6
HeadacheNervous system disorders	3/6	0/6	1/4	0/4	0/3	0/6
Nasal congestionRespiratory, thoracic and mediastinal disorders	0/6	0/6	0/4	2/4	0/3	0/6
DiarrhoeaGastrointestinal disorders	2/6	0/6	1/4	1/4	0/3	0/6
DysgeusiaNervous system disorders	2/6	0/6	1/4	0/4	0/3	0/6
VomitingGastrointestinal disorders	1/6	0/6	1/4	0/4	0/3	0/6
ChillsGeneral disorders	0/6	0/6	1/4	0/4	0/3	0/6
Upper respiratory tract infectionInfections and infestations	0/6	0/6	1/4	0/4	0/3	0/6
DizzinessNervous system disorders	0/6	0/6	1/4	0/4	0/3	0/6
CoughRespiratory, thoracic and mediastinal disorders	0/6	0/6	0/4	1/4	0/3	0/6

Baseline characteristics

The safety set included all participants who received at least one dose of the study drug (active or placebo).

Age, Continuous
Age, Continuous(years)	Sequence 1: Placebo + TAK-954 1 mg + TAK-954 2 mg	Sequence 2: TAK-954 0.5 mg + Placebo + TAK-954 2 mg	Sequence 3: TAK-954 0.5 mg + TAK-954 1 mg + Placebo	Total
Mean	28.0 ± 14.14	33.0 ± 4.24	46.5 ± 2.12	35.8 ± 10.85

Sex: Female, Male
Sex: Female, Male(Participants)	Sequence 1: Placebo + TAK-954 1 mg + TAK-954 2 mg	Sequence 2: TAK-954 0.5 mg + Placebo + TAK-954 2 mg	Sequence 3: TAK-954 0.5 mg + TAK-954 1 mg + Placebo	Total
Female	1	1	2	4
Male	1	1	0	2

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Sequence 1: Placebo + TAK-954 1 mg + TAK-954 2 mg	Sequence 2: TAK-954 0.5 mg + Placebo + TAK-954 2 mg	Sequence 3: TAK-954 0.5 mg + TAK-954 1 mg + Placebo	Total
Hispanic or Latino	2	2	2	6
Not Hispanic or Latino	0	0	0	0
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Sequence 1: Placebo + TAK-954 1 mg + TAK-954 2 mg	Sequence 2: TAK-954 0.5 mg + Placebo + TAK-954 2 mg	Sequence 3: TAK-954 0.5 mg + TAK-954 1 mg + Placebo	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	0	0	0	0
White	2	2	2	6
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Sequence 1: Placebo + TAK-954 1 mg + TAK-954 2 mg	Sequence 2: TAK-954 0.5 mg + Placebo + TAK-954 2 mg	Sequence 3: TAK-954 0.5 mg + TAK-954 1 mg + Placebo	Total
United States	2	2	2	6

Weight
Weight(kilogram)	Sequence 1: Placebo + TAK-954 1 mg + TAK-954 2 mg	Sequence 2: TAK-954 0.5 mg + Placebo + TAK-954 2 mg	Sequence 3: TAK-954 0.5 mg + TAK-954 1 mg + Placebo	Total
Mean	84.80 ± 13.152	67.60 ± 9.758	80.55 ± 0.495	77.65 ± 10.858

Height
Height(centimeter (cm))	Sequence 1: Placebo + TAK-954 1 mg + TAK-954 2 mg	Sequence 2: TAK-954 0.5 mg + Placebo + TAK-954 2 mg	Sequence 3: TAK-954 0.5 mg + TAK-954 1 mg + Placebo	Total
Mean	168.5 ± 7.78	167.0 ± 21.21	165.5 ± 4.95	167.0 ± 10.43

Body Mass Index (BMI)
Body Mass Index (BMI)(kilogram per square meter (kg/m^2))	Sequence 1: Placebo + TAK-954 1 mg + TAK-954 2 mg	Sequence 2: TAK-954 0.5 mg + Placebo + TAK-954 2 mg	Sequence 3: TAK-954 0.5 mg + TAK-954 1 mg + Placebo	Total
Mean	29.655 ± 1.9021	24.375 ± 2.5102	29.455 ± 1.7607	27.828 ± 3.1252

Study locations

1 site

Celerion
Tempe, Arizona 85283, United States

References and documents

Study documents

Study protocol · Mar 11, 2019
Statistical analysis plan · Mar 18, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03870555
Lead sponsor: Millennium Pharmaceuticals, Inc.
Responsible party: Sponsor
First posted: Mar 12, 2019
Start date: Mar 8, 2019
Primary completion: May 16, 2019
Completion: May 16, 2019
Results posted: Jun 24, 2020
Last update: Jun 24, 2020

Study contacts

Medical Director

study director · Millennium Pharmaceuticals, Inc.

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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