Healthy ParticipantsPhase 1NCT03161405

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

A Phase 1 study testing TAK-906 Maleate and Itraconazole in people with Healthy Participants, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: TAK-906 Maleate and Itraconazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 5 Jun 2017to 10 Jul 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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) 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.
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.

Who cannot join

Has a positive alcohol or drug screen.
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.
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Takeda Investigational Site
Lenexa, Kansas, 66219

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Conditions: Healthy Participants
Being tested: TAK-906 Maleate, Itraconazole
Keywords: Drug Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAK-906 MaleateDrug
TAK-906 capsule
ItraconazoleDrug
Itraconazole solution

Study groups in NCT03161405
Study group	Role	What they receive
TAK-906 maleate 25mg;Itraconazole 200mg + TAK-906 maleate 25mg	Experimental	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. Receives: Drug: TAK-906 Maleate; Drug: Itraconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax: Maximum Observed Plasma Concentration for TAK-906
Measured: 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
Measured: 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
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jun 201710 Jul 2017

First posted19 May 2017
Study start5 Jun 2017
Primary completion2 Jul 2017
Study completion10 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03161405
Sponsor's protocol ID: TAK-906-1003
Other IDs: U1111-1192-7802
Status last verified: Jul 2018
First submitted: 18 May 2017
Last updated: 11 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers

All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03161405
Acronym / sponsor ID: TAK-906-1003
Conditions: Healthy Participants
Keywords: Drug Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 5 Jun 2017 (actual)
Primary completion: 2 Jul 2017 (actual)
Study completion: 10 Jul 2017 (actual)
First posted: 19 May 2017 (actual)
Results: Posted 11 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TAK-906 maleate 25mg;Itraconazole 200mg + TAK-906 maleate 25mg	Experimental	Drug: TAK-906 Maleate, Drug: ItraconazoleTAK-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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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) 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.
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.

Key exclusion criteria (5 listed)

Has a positive alcohol or drug screen.
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.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAK-906 MaleateTAK-906 capsule	Drug	TAK-906 maleate 25mg;Itraconazole 200mg + TAK-906 maleate 25mg
ItraconazoleItraconazole solution	Drug	TAK-906 maleate 25mg;Itraconazole 200mg + TAK-906 maleate 25mg

Primary outcome

Cmax: Maximum Observed Plasma Concentration for TAK-906
Time frame: 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
Time frame: 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
Time frame: 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

Results and safety

Results posted to the registry on 11 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAK-906 Maleate 25mg;Itraconazole 200mg + TAK-906 Maleate 25mg	12	12

Primary outcome: Cmax: Maximum Observed Plasma Concentration for TAK-906

Time frame: 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. Geometric mean (Standard Deviation). Unit: nanogram per milliliter (ng/mL)

Measure	TAK-906 Maleate 25 mg n = 12	Itraconazole 200 mg + TAK-906 Maleate 25 mg n = 11
Value	9.532 (4.6337)	17.999 (4.8780)

TAK-906 Maleate 25 mg vs Itraconazole 200 mg + TAK-906 Maleate 25 mg: Geometric mean ratio: 1.9827 (90% CI 1.6446 to 2.3904)

Population analysed: The pharmacokinetic (PK) analysis set included all participants from the safety set who had at least 1 measurable post-dose TAK-906 plasma concentration.

Primary outcome: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906

Measure	TAK-906 Maleate 25 mg n = 12	Itraconazole 200 mg + TAK-906 Maleate 25 mg n = 11
Value	24.10 (8.173)	30.73 (8.521)

TAK-906 Maleate 25 mg vs Itraconazole 200 mg + TAK-906 Maleate 25 mg: Geometric mean ratio: 1.2914 (90% CI 1.1199 to 1.4891)

Population analysed: The PK analysis set included all participants from the safety set who had at least 1 measurable post-dose TAK-906 plasma concentration.

Primary outcome: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906

Measure	TAK-906 Maleate 25 mg n = 12	Itraconazole 200 mg + TAK-906 Maleate 25 mg n = 11
Value	24.41 (8.136)	31.45 (8.995)

TAK-906 Maleate 25 mg vs Itraconazole 200 mg + TAK-906 Maleate 25 mg: Geometric mean ratio: 1.2783 (90% CI 1.0965 to 1.4904)

Population analysed: The PK analysis set included all participants from the safety set who had at least 1 measurable post-dose TAK-906 plasma concentration. PK analysis set where Day 1 and 4 assessments were available.

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose study drug up to 30 days after the last dose of study (approximately Day 36). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAK-906 Maleate 25 mg	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Itraconazole 200 mg	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11
Itraconazole 200 mg + TAK-906 Maleate 25 mg	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Healthy Participants

RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-906 Maleate and Itraconazole in people with Healthy Participants, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax: Maximum Observed Plasma Concentration for TAK-906 (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03161405.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.