A Single-Sequence, Open-Label, 2-Period, Crossover Trial to Evaluate the Effect of the Potent CYP3A4 Inhibitor Itraconazole on the Single-Dose Pharmacokinetics of Oral TAK-906 in Healthy Adult Subjects.

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



Sponsors


Source

Takeda

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

Yes

Is Fda Regulated Device

No


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 will enroll approximately 12 participants. Participants will receive the following
treatment sequence:

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

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

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 remain confined in the clinic
from Day 1 up to Day 2 (First Intervention Period) and Day 4 up Day 6 (Second Intervention
Period). Participants will return for a Follow-up Visit, 10 to 14 days after last dose of
study drug.

Overall Status

Not yet recruiting

Start Date

2017-05-26

Completion Date

2017-07-10

Primary Completion Date

2017-07-10

Phase

Phase 1

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Cmax: Maximum Observed Plasma Concentration for TAK-906 on Day 1 of First Intervention Period
Day 1: Pre-dose and at multiple time points (up to 48 hours) post-dose of First Intervention Period
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 on Day 1 of First Intervention Period
Day 1: Pre-dose and at multiple time points (up to 48 hours) post-dose of First Intervention Period
AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-906 on Day 1 of First Intervention Period
Day 1: Pre-dose and at multiple time points (up to 48 hours) post-dose of First Intervention Period
Cmax: Maximum Observed Plasma Concentration for TAK-906 on Day 4 of Second Intervention Period
Day 4: Pre-dose and at multiple time points (up to 48 hours) post-dose of Second Intervention Period
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 on Day 4 of Second Intervention Period
Day 4: Pre-dose and at multiple time points (up to 48 hours) post-dose of Second Intervention Period
AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-906 on Day 4 of Second Intervention Period
Day 4: Pre-dose and at multiple time points (up to 48 hours) post-dose of Second Intervention Period

Enrollment

12

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

TAK-906 capsule

Arm Group Label

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


Intervention Type

Drug

Intervention Name


Description

Itraconazole solution

Arm Group Label

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



Eligibility

Criteria

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.

Gender

All

Minimum Age

18 Years

Maximum Age

55 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

Medical Director
Study Director
Takeda

Overall Contact

Last Name

Takeda Study Registration Call Center

Phone

+1-877-825-3327

Email

[email protected]


Verification Date

2017-05-01

Lastchanged Date

2017-05-18

Firstreceived Date

2017-05-18

Responsible Party

Responsible Party Type

Sponsor


Keyword


Has Expanded Access

No

Secondary Id

U1111-1192-7802

Number Of Arms

1

Intervention Browse

Mesh Term

Itraconazole

Hydroxyitraconazole

Cytochrome P-450 CYP3A Inhibitors

Maleic acid



Arm Group

Arm Group Label

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

Arm Group Type

Experimental

Description

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.


Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Primary Purpose

Other

Masking

No masking



ClinicalTrials.gov processed this data on May 19, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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