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

NCT03173170 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: TAK-954-10042017-000713-22U1111-1195-7682
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Drug: TAK-954; Drug: Itraconazole

Interventions

TAK-954 DRUG

TAK-954 Infusion

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

Itraconazole DRUG

Itraconazole Capsule

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is a man or woman (with no child bearing potential) aged 18 to 55 years, inclusive, at the Screening Visit.
• 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.
• 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.

You may not qualify if:

• Has a positive alcohol or drug screen.
• Had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter (mL)) within 8 weeks of the first dose of study drug.
• 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).
• 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.
• Has a substance abuse disorder.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Pharmaceutical Research Associates, Inc.

Lenexa, Kansas, 66219, United States

Location

Related Publications (1)

• 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.

  PMID: 34989180 DERIVED

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 1, 2017
• Study Start: May 31, 2017
• Primary Completion: July 24, 2017
• Study Completion: July 24, 2017
• Last Updated: January 15, 2019
• Results First Posted: January 15, 2019

Record last verified: 2018-07

Locations

US (1)