A Study to Evaluate the Effect of the Potent CYP3A4 Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-906 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: TAK-906 Maleate; Drug: Itraconazole

• Registration Number: NCT03161405
• Lead Sponsor: Millennium Pharmaceuticals, Inc.

Brief Summary

The purpose of this study is to evaluate the effect of the potent cytochrome P-450 (CYP) 3A4 inhibitor (itraconazole) on the single-dose PK of oral TAK-906 maleate.

Detailed Description

The drug being tested in this study is called TAK-906. TAK-906 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-906 maleate.

The study enrolled 12 participants. Participants received the following treatment sequence:

• TAK-906 maleate 25 mg; Itraconazole 200 mg + TAK-906 maleate 25 mg

Participants were given an oral dose of TAK-906 in the First Intervention Period which was followed by a washout period, after which participants were given Itraconazole solution along with TAK-906 orally in the Second Intervention Period.

This single center trial was conducted in the United States. The overall duration to participate in this study was 7 weeks. Participants remained confined in the clinic from Day 1 up to Day 2 (First Intervention Period) and Day 4 up Day 6 (Second Intervention Period). Participants returned for a Follow-up Visit, 10 to 14 days after last dose of study drug.

Study Timeline

• Study First Submitted: 2017-05-18
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-19
• Study Start: 2017-06-05
• Primary Completion: 2017-07-02
• Study Completion: 2017-07-10
• Status Verified: 2018-07
• Results First Submitted: 2018-07-02
• Results First Submitted QC: 2018-07-02
• Last Update Submitted: 2018-07-02
• Results First Posted: 2019-01-11
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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) greater than or equal to (>=) 18 and less than or equal to (<=) 30 kilogram per square meter (kg/m^2) and 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

1. Has a positive alcohol or drug screen.
2. Has had a 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAK-906 maleate 25mg;Itraconazole 200mg + TAK-906 maleate 25mg	TAK-906 Maleate	TAK-906 maleate 25 milligram (mg), capsule, orally, once on Day 1 of First Intervention Period, followed by a minimum of 4-day washout period, further followed by Itraconazole 200 mg, solution, orally, once daily on Days 1 to 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.
TAK-906 maleate 25mg;Itraconazole 200mg + TAK-906 maleate 25mg	Itraconazole	TAK-906 maleate 25 milligram (mg), capsule, orally, once on Day 1 of First Intervention Period, followed by a minimum of 4-day washout period, further followed by Itraconazole 200 mg, solution, orally, once daily on Days 1 to 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.

Primary Outcome Measures

Name	Time	Method
Cmax: Maximum Observed Plasma Concentration for TAK-906	TAK-906 maleate 25mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 maleate-dose; Itraconazole 200 mg + TAK-906 maleate 25mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 maleate-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906	TAK-906 maleate 25mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 maleate-dose; Itraconazole 200 mg + TAK-906 maleate 25mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 maleate-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906	TAK-906 maleate 25mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 maleate-dose; Itraconazole 200 mg + TAK-906 maleate 25mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 maleate-dose

Trial Locations

Locations (1)

Takeda Investigational Site; 🇺🇸 Lenexa, Kansas, United States