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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000713-22 | EudraCT Number | ||
| U1111-1195-7682 | Registry Identifier | WHO |
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The purpose of this study is to evaluate the effect of the potent CYP3A4 inhibitor itraconazole on the single-dose PK of TAK-954.
The drug being tested in this study is called TAK-954. TAK-954 is being tested in healthy participants in order to evaluate the effect of the potent CYP3A4 inhibitor itraconazole on the single-dose PK of TAK-954.
The study will enroll approximately 10 participants. Participants will receive the following treatment sequences:
• TAK-954 0.2 mg; Itraconazole 200 mg + TAK-954 0.2 mg
Participants will be given an intravenous infusion of TAK-954 on Day 1 of First Intervention Period (6 days) followed by minimum 7-day washout period, after which participants will be given Itraconazole capsule on Days 1 to 8 along with TAK-945 infusion on Day 4 of Second Intervention Period (9 days).
This single center trial will be conducted in the United States. The overall duration to participate in this study is 7 to 8 weeks. Participants will visit the clinic on Day -1 and remained confined until Day 6 (First Intervention Period) and Day 9 (Second Intervention Period). Participants will return for a Follow-up Visit 10 to 14 days after last dose of study drug (approximately up to Day 34).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg | Experimental | TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1 of First Intervention Period, followed by a minimum of 7-day washout period, further followed by Itraconazole 200 mg, capsule, orally, once daily on Days 1 to 8 along with TAK-954 0.2 mg, infusion, intravenously on Day 4 of Second Intervention Period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-954 | Drug | TAK-954 Infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for TAK-954 | TAK-954 0.2 mg: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose; Itraconazole 200 mg and TAK-954 0.2 mg: Day 4 pre-dose and at multiple time points (up to 120 hours) post-dose | |
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 | TAK-954 0.2 mg: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose; Itraconazole 200 mg and TAK-954 0.2mg: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaceutical Research Associates, Inc. | Lenexa | Kansas | 66219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34989180 | Derived | Chen C, Zhang L, Almansa C, Rosario M, Cwik M, Balani SK, Lock R. Evaluation of the Pharmacokinetics of Felcisetrag (TAK-954), a 5-HT4 Receptor Agonist, in the Presence and Absence of Itraconazole, a Potent CYP3A4 Inhibitor. Clin Pharmacol Drug Dev. 2022 Feb;11(2):142-149. doi: 10.1002/cpdd.1046. Epub 2022 Jan 6. |
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Healthy participants were enrolled in this single sequence 2-period crossover study to receive TAK-954 0.2 milligram (mg) in Intervention Period 1 followed by itraconazole 200 mg + TAK-954 0.2 mg in Intervention Period 2.
Participants took part in the study at 1 investigative site in United States from 31 May 2017 to 24 July 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg | TAK-954 0.2 mg, infusion, intravenously, once on Day 1 of First Intervention Period, followed by a minimum of 7-day washout period, further followed by itraconazole 200 mg, capsule, orally, once daily on Days 1 to 8 along with TAK-954 0.2 mg, infusion, intravenously on Day 4 of Second Intervention Period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention Period (6 Days) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 3, 2017 | Jul 20, 2018 |
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| Itraconazole |
| Drug |
Itraconazole Capsule |
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| COMPLETED |
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| NOT COMPLETED |
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| Washout Period (at Least 7 Days) |
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| Intervention Period 2 (9 Days) |
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The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | TAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg | TAK-954 0.2 mg, infusion, intravenously, once on Day 1 of First Intervention Period, followed by a minimum of 7-day washout period, further followed by itraconazole 200 mg, capsule, orally, once daily on Days 1 to 8 along with TAK-954 0.2 mg, infusion, intravenously on Day 4 of Second Intervention Period. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kilogram (kg) |
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| Height | Mean | Standard Deviation | centimeter (cm) |
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| Body mass index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Cmax: Maximum Observed Plasma Concentration for TAK-954 | The pharmacokinetic (PK) set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration. | Posted | Geometric Mean | Standard Deviation | nanogram/milliliter (ng/mL) | TAK-954 0.2 mg: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose; Itraconazole 200 mg and TAK-954 0.2 mg: Day 4 pre-dose and at multiple time points (up to 120 hours) post-dose |
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| Primary | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 | The PK set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration. PK analysis set where Day 1 and 4 assessments were available. | Posted | Geometric Mean | Standard Deviation | hour*nanogram per milliliter (hr*ng/mL) | TAK-954 0.2 mg: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose; Itraconazole 200 mg and TAK-954 0.2mg: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose |
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Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 9 of Second Intervention Period
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAK-954 0.2 mg | TAK-954 0.2 mg, infusion, intravenously, once on Day 1 of First Intervention Period. | 0 | 10 | 0 | 10 | 3 | 10 |
| EG001 | Itraconazole 200 mg | Itraconazole 200 mg, capsule, orally, once daily on Days 1 to 3 of Second Intervention Period. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Itraconazole 200 mg and TAK-954 0.2 mg | Itraconazole 200 mg, capsule, orally, once daily on Days 4 to 8 along with TAK-954 0.2 mg, infusion, intravenously on Day 4 of Second Intervention Period. | 0 | 10 | 0 | 10 | 1 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal incontinence | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 8, 2017 | Jul 20, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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