CClinicalTrials.gg
Sign In
CompletedNCT03173170Updated Jan 15, 2019Results posted

A Study to Evaluate the Effect of the Potent Cytochrome P-450 3A4 (CYP3A4) Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-954 in Healthy Adult Participants

A Phase 1 interventional study of TAK-954 and Itraconazole in Healthy Participants, sponsored by Takeda. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-15.

Sponsored by Takeda · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the effect of the potent CYP3A4 inhibitor itraconazole on the single-dose PK of TAK-954.

Read the detailed description

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).

02

Conditions studied

  • Healthy Participants

Keywords

  • Drug Therapy
03

In context

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

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

04

Who can participate

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

Inclusion criteria

  1. Is a man or woman (with no child bearing potential) aged 18 to 55 years, inclusive, at the Screening Visit.
  2. Has a body mass index (BMI) from greater than or equal to (>=) 18 and less than or equal to (\<=) 30 kilogram per square meter (kg/m\^2) and has a body weight greater than (>) 50 kilogram (kg) at the Screening Visit.
  3. Is a nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before administration of the initial dose of trial drug/invasive procedure.

Exclusion criteria

Exclusion Criteria:

  1. Has a positive alcohol or drug screen.
  2. Had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter (mL)) within 8 weeks of the first dose of study drug.
  3. Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce] per day).
  4. Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
  5. Has a substance abuse disorder.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    TAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg

    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.

    Drug: TAK-954 · Drug: Itraconazole

Interventions

  • DrugTAK-954

    TAK-954 Infusion

  • DrugItraconazole

    Itraconazole Capsule

06

What researchers measure

Primary outcomes

  1. Cmax: Maximum Observed Plasma Concentration for TAK-954

    Time frame: 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

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

    Time frame: 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

07

Results

Posted Jan 15, 2019

Participant flow

Participants took part in the study at 1 investigative site in United States from 31 May 2017 to 24 July 2017.

First Intervention Period (6 Days)
Participant flow — First Intervention Period (6 Days)
MilestoneTAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg
Started10
Completed10
Not completed0
Washout Period (at Least 7 Days)
Participant flow — Washout Period (at Least 7 Days)
MilestoneTAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg
Started10
Completed10
Not completed0
Intervention Period 2 (9 Days)
Participant flow — Intervention Period 2 (9 Days)
MilestoneTAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg
Started10
Completed10
Not completed0

Outcome measures

PrimaryCmax: Maximum Observed Plasma Concentration for TAK-954
Time frame:
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
Reported as:
Geometric mean · nanogram/milliliter (ng/mL)
Cmax: Maximum Observed Plasma Concentration for TAK-954
nanogram/milliliter (ng/mL)TAK-954 0.2 mgItraconazole 200 mg and TAK-954 0.2 mg
Cmax: Maximum Observed Plasma Concentration for TAK-9542.642 ± 0.44262.840 ± 0.6497
Statistical analysis
  • TAK-954 0.2 mg vs Itraconazole 200 mg and TAK-954 0.2 mg · Mean ratio: 1.0622 · 90% CI 0.9569 to 1.1792
PrimaryAUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954
Time frame:
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
Reported as:
Geometric mean · hour*nanogram per milliliter (hr*ng/mL)
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954
hour*nanogram per milliliter (hr*ng/mL)TAK-954 0.2 mgItraconazole 200 mg and TAK-954 0.2mg
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-95428.59 ± 6.55043.15 ± 10.265
Statistical analysis
  • TAK-954 0.2 mg vs Itraconazole 200 mg and TAK-954 0.2mg · Mean ratio: 1.4892 · 90% CI 1.3851 to 1.6012

Adverse events

Collected over Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 9 of Second Intervention Period. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TAK-954 0.2 mg0/10 (0%)0/10 (0%)3/10 (30%)
Itraconazole 200 mg0/10 (0%)0/10 (0%)0/10 (0%)
Itraconazole 200 mg and TAK-954 0.2 mg0/10 (0%)0/10 (0%)1/10 (10%)
Most frequent other events
Most frequent other events
EventTAK-954 0.2 mgItraconazole 200 mgItraconazole 200 mg and TAK-954 0.2 mg
HeadacheNervous system disorders3/100/101/10
Anal incontinenceGastrointestinal disorders1/100/100/10
DiarrhoeaGastrointestinal disorders1/100/100/10
PresyncopeNervous system disorders1/100/100/10

Baseline characteristics

The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.

Age, Continuous
Age, Continuous(years)TAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg
Mean34.7 ± 10.34
Sex: Female, Male
Sex: Female, Male(Participants)TAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg
Female1
Male9
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)TAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg
Hispanic or Latino0
Not Hispanic or Latino10
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)TAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American2
White8
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)TAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg
United States10
Weight
Weight(kilogram (kg))TAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg
Mean73.72 ± 11.534
Height
Height(centimeter (cm))TAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg
Mean174.4 ± 10.17
Body mass index (BMI)
Body mass index (BMI)(kilogram per square meter (kg/m^2))TAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg
Mean24.2 ± 2.90
08

Study locations

1 site
  • Pharmaceutical Research Associates, Inc.
    Lenexa, Kansas 66219, United States
09

References and documents

Publications

  • 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. PubMed 34989180 ↗

Study documents

  • Study protocol · May 3, 2017
  • Statistical analysis plan · Aug 8, 2017

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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03173170
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Jun 1, 2017
Start date
May 31, 2017
Primary completion
Jul 24, 2017
Completion
Jul 24, 2017
Results posted
Jan 15, 2019
Last update
Jan 15, 2019

Study contacts

Medical Director
study director · Takeda

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Takeda

Start the discussion