Neoplasm, Advanced or MetastaticPhase 1NCT02625259

A Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics of TAK-117 (MLN1117) in Healthy Participants

A Phase 1 study testing TAK-117 and Lansoprazole in people with Neoplasm, Advanced or Metastatic, run by Millennium Pharmaceuticals, Inc..

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate the relative bioavailability of a new tablet formulation of TAK-117 (new clinical trial material [NTM]) compared to the TAK-117 Process B capsules (current clinical trial material [CTM]) (Part 1), to assess the effects of food on the oral bioavailability and pharmacokinetics… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Neoplasm, Advanced or Metastatic
What is being tested?: TAK-117 and Lansoprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: No sites listed yet
Study dates: 8 Jan 2016to 22 Jul 2016
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Is aged 18 to 45 years inclusive, at the time of consent.
Is healthy adult male or female.
Weighs greater than or equal to (>=) 45 kilogram (kg) (female) or >=55 kg (male), and body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2), inclusive, at screening.
Suitable venous access for the study-required blood sampling, including PK sampling.
Has provided the voluntary written consent.

Who cannot join

Any clinically significant abnormality at screening or medical history of cardiac, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Manifestations of malabsorption due to prior GI surgery, GI disease, or for an unknown other reason that may alter the PK of TAK-117 or lansoprazole.
Creatinine clearance less than or equal to (<=) 90 milliliter per minute (mL/min) based either on Cockroft-Gault estimate or based on a 12- or 24-hour urine collection during screening.
Known intolerance to TAK-117 or lansoprazole, or any of the excipients of either drug.
A positive test result for human immunodeficiency virus (HIV), hepatitis A antibody (HAVAb), hepatitis B surface antigen (HBsAg), hepatitis B core (HBc) antibody Anti-HBc (IgM), or hepatitis C antibody (HCVAb) tests at screening, or serological reactions for syphilis during screening.
Has Lactose intolerance (only for Part 2).

About this study

Official title: A Phase 1, Open-Label Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric pH Modification on the Pharmacokinetics of MLN1117 in Healthy Subjects

Read the detailed description

The drug being tested in this study is called TAK-117. TAK-117 is being tested to treat people who have advanced solid tumors. This study will look at the PK and relative bioavailability of new tablet formulation of TAK-117 as compare to current capsule formulation in Part 1. In Part 2 and Part 3, interaction of TAK-117 with food and a gastric pH modifying agent will be evaluated respectively in healthy participants, and will commence only after the completion of Part 1.

The study will enroll approximately 54 participants. In Part 1, participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 2 crossover sequences:

Sequence A: TAK-117 capsules (9*100 mg) first then TAK-117 tablets (3*300 mg)
Sequence B: TAK-117 tablets (3*300 mg) first then TAK-117 capsules (9*100 mg)

Part 2 and Part 3 will be evaluated only on the new tablet formulation of TAK-117 at the dose determined in Part 1. In Part 2, participants will be randomly assigned to receive a single dose of TAK-117 in the fasted state followed by TAK-117 with standard high-fat breakfast in Sequence A or vice-versa in Sequence B. In Part 3, participants will receive a single dose of TAK-117 on Day 1 followed by lansoprazole 30 mg on Day 10 for 6 days and then second dose of TAK-117 on Day 15. Blood samples will be collected at predose and up to 72 hours postdose at prespecified time points on Days 1 and 15. Urine samples will be collected predose, 0 to 12 hours, and 12 to 24 hours postdose in Part 1 only.

This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 45 days. Participants will make 2 visits to the clinic in each part, during which they will remain confined to the clinic for a 4 to 10 day period for drug dosing and other study procedures. Participants will also complete a final visit 30 to 33 days after their last dose of study drug for a follow-up assessment (Day 45).

Conditions: Neoplasm, Advanced or Metastatic
Being tested: TAK-117, Lansoprazole
Keywords: Drug therapy
Medical subject headings: Neoplasms, Neoplasm Metastasis

What participants receive

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

TAK-117Drug
TAK-117 capsules
LansoprazoleDrug
Lansoprazole capsules
TAK-117Drug
TAK-117 tablets

Study groups in NCT02625259
Study group	Role	What they receive
Part 1: TAK-117 9100 mg + TAK-117 3300 mg	Experimental	TAK-117900 milligram (mg), capsules, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 900 mg, tablets, orally, once on Day 15. Receives: Drug: TAK-117
Part 1: TAK-117 3300 mg + TAK-117 9100 mg	Experimental	TAK-117 900 mg tablets, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 900 mg, capsules, orally, once on Day 15. Receives: Drug: TAK-117
Part 2: TAK-117 Fasted + TAK-117 Fed	Experimental	TAK-117 at the dose determined in Part 1, tablets, in fasted condition, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 at the dose determined in Part 1, tablets, with a standard high-fat meal, orally, once on Day 15. Receives: Drug: TAK-117
Part 2: TAK-117 Fed + TAK-117 Fasted	Experimental	TAK-117 at the dose determined in Part 1, tablets, with a standard high-fat meal, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 at the dose determined in Part 1, tablets, in fasted condition, orally, once on Day 15. Receives: Drug: TAK-117
Part 3: TAK-117 + Lansoprazole	Experimental	TAK-117 at the dose determined in Part 1, tablets, orally, once on Day 1, followed by lansoprazole 30 mg, tablets or capsules, once daily from Day 10 to Day 15, followed by TAK-117 at the dose determined in Part 1, tablets, orally, once on Day 15. Receives: Drug: Lansoprazole; Drug: TAK-117

What is being measured

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

Cmax: Maximum Observed Plasma Concentration for TAK-117
Measured: Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117
Measured: Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-117
Measured: Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-117
Measured: Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose

Secondary outcomes (1)

Part 1: Renal Clearance (CLr) of TAK-117
Measured: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

Timeline

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

8 Jan 201622 Jul 2016

First posted9 Dec 2015 (estimated)
Study start8 Jan 2016
Primary completion16 May 2016
Study completion22 Jul 2016

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 Neoplasm, Advanced or MetastaticStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02625259
Sponsor's protocol ID: MLN1117-1002
Other IDs: U1111-1159-5909
Status last verified: Jul 2017
First submitted: 4 Dec 2015
Last updated: 8 Jan 2018
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?

Official record

Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer

All Neoplasm, Advanced or Metastatic trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric pH Modification on the Pharmacokinetics of MLN1117 in Healthy Subjects
ClinicalTrials.gov ID: NCT02625259
Acronym / sponsor ID: MLN1117-1002
Conditions: Neoplasm, Advanced or Metastatic
Keywords: Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 8 Jan 2016 (actual)
Primary completion: 16 May 2016 (actual)
Study completion: 22 Jul 2016 (actual)
First posted: 9 Dec 2015 (estimated)
Results: Posted 8 Jan 2018

Clinical summary

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

Detailed description

The study will enroll approximately 54 participants. In Part 1, participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 2 crossover sequences:

Sequence A: TAK-117 capsules (9*100 mg) first then TAK-117 tablets (3*300 mg)
Sequence B: TAK-117 tablets (3*300 mg) first then TAK-117 capsules (9*100 mg)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Part 1: TAK-117 9100 mg + TAK-117 3300 mg	Experimental	Drug: TAK-117TAK-117900 milligram (mg), capsules, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 900 mg, tablets, orally, once on Day 15.
Part 1: TAK-117 3300 mg + TAK-117 9100 mg	Experimental	Drug: TAK-117TAK-117 900 mg tablets, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 900 mg, capsules, orally, once on Day 15.
Part 2: TAK-117 Fasted + TAK-117 Fed	Experimental	Drug: TAK-117TAK-117 at the dose determined in Part 1, tablets, in fasted condition, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 at the dose determined in Part 1, tablets, with a standard high-fat meal, orally, once on Day 15.
Part 2: TAK-117 Fed + TAK-117 Fasted	Experimental	Drug: TAK-117TAK-117 at the dose determined in Part 1, tablets, with a standard high-fat meal, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 at the dose determined in Part 1, tablets, in fasted condition, orally, once on Day 15.
Part 3: TAK-117 + Lansoprazole	Experimental	Drug: Lansoprazole, Drug: TAK-117TAK-117 at the dose determined in Part 1, tablets, orally, once on Day 1, followed by lansoprazole 30 mg, tablets or capsules, once daily from Day 10 to Day 15, followed by TAK-117 at the dose determined in Part 1, tablets, orally, once on Day 15.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Is aged 18 to 45 years inclusive, at the time of consent.
Is healthy adult male or female.
Weighs greater than or equal to (>=) 45 kilogram (kg) (female) or >=55 kg (male), and body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2), inclusive, at screening.
Suitable venous access for the study-required blood sampling, including PK sampling.
Has provided the voluntary written consent.

Key exclusion criteria (6 listed)

Any clinically significant abnormality at screening or medical history of cardiac, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Manifestations of malabsorption due to prior GI surgery, GI disease, or for an unknown other reason that may alter the PK of TAK-117 or lansoprazole.
Creatinine clearance less than or equal to (<=) 90 milliliter per minute (mL/min) based either on Cockroft-Gault estimate or based on a 12- or 24-hour urine collection during screening.
Known intolerance to TAK-117 or lansoprazole, or any of the excipients of either drug.
A positive test result for human immunodeficiency virus (HIV), hepatitis A antibody (HAVAb), hepatitis B surface antigen (HBsAg), hepatitis B core (HBc) antibody Anti-HBc (IgM), or hepatitis C antibody (HCVAb) tests at screening, or serological reactions for syphilis during screening.

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-117TAK-117 capsules	Drug	Part 1: TAK-117 3300 mg + TAK-117 9100 mg, Part 1: TAK-117 9100 mg + TAK-117 3300 mg
LansoprazoleLansoprazole capsules	Drug	Part 3: TAK-117 + Lansoprazole
TAK-117TAK-117 tablets	Drug	Part 1: TAK-117 3300 mg + TAK-117 9100 mg, Part 1: TAK-117 9100 mg + TAK-117 3300 mg, Part 2: TAK-117 Fasted + TAK-117 Fed, Part 2: TAK-117 Fed + TAK-117 Fasted, Part 3: TAK-117 + Lansoprazole

Primary outcome

Cmax: Maximum Observed Plasma Concentration for TAK-117
Time frame: Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117
Time frame: Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-117
Time frame: Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-117
Time frame: Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose

1 secondary outcome

Part 1: Renal Clearance (CLr) of TAK-117
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

Results and safety

Results posted to the registry on 8 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part-1: TAK-117 900 mg Capsules + TAK-117 900 mg Tablets	11	9
Part-1: TAK-117 900 mg Tablets + TAK-117 900 mg Capsules	9	8
Part-2: TAK-117 600 mg Fasted + TAK-117 600 mg Fed	8	7
Part-2: TAK-117 600 mg Fed + TAK-117 600 mg Fasted	10	9
Part-3: TAK-117 900 mg + Lansoprazole 30 mg	16	16

Primary outcome: Cmax: Maximum Observed Plasma Concentration for TAK-117

Time frame: Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules) n = 17	Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets) n = 17	Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets) n = 16	Part-2: TAK-117 600 mg Fed (2*300 mg Tablets) n = 16	Part-3: TAK-117 900 mg (3*300 mg Tablets) n = 16	Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg n = 16
Value	4632.992 (71)	6225.347 (53)	6455.111 (48)	7847.591 (24)	5859.156 (58)	190.172 (144)

Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules) vs Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets): Geometric mean ratio: 1.36 (90% CI 1.00 to 1.83)
Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets) vs Part-2: TAK-117 600 mg Fed (2*300 mg Tablets): Geometric mean ratio: 1.20 (90% CI 0.86 to 1.67)
Part-3: TAK-117 900 mg (3*300 mg Tablets) vs Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg: Geometric mean ratio: 0.03 (90% CI 0.02 to 0.07)

Population analysed: The pharmacokinetic (PK)-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.

Primary outcome: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117

Measure	Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules) n = 17	Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets) n = 17	Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets) n = 16	Part-2: TAK-117 600 mg Fed (2*300 mg Tablets) n = 16	Part-3: TAK-117 900 mg (3*300 mg Tablets) n = 16	Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg n = 16
Value	2.067 (1.00 to 6.00)	3.000 (0.500 to 6.00)	3.000 (2.00 to 6.07)	6.033 (4.00 to 8.03)	3.000 (1.00 to 6.00)	3.517 (1.00 to 6.00)

Population analysed: The PK-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.

Primary outcome: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-117

Measure	Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules) n = 17	Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets) n = 17	Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets) n = 16	Part-2: TAK-117 600 mg Fed (2*300 mg Tablets) n = 16	Part-3: TAK-117 900 mg (3*300 mg Tablets) n = 16	Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg n = 16
Value	45727.280 (94)	66015.952 (91)	71442.968 (67)	127143.511 (39)	63165.064 (91)	1018.650 (129)

Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules) vs Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets): Geometric mean ratio: 1.47 (90% CI 0.98 to 2.18)
Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets) vs Part-2: TAK-117 600 mg Fed (2*300 mg Tablets): Geometric mean ratio: 1.76 (90% CI 1.11 to 2.78)
Part-3: TAK-117 900 mg (3*300 mg Tablets) vs Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg: Geometric mean ratio: 0.02 (90% CI 0.01 to 0.04)

Primary outcome: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-117

Measure	Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules) n = 13	Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets) n = 13	Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets) n = 15	Part-2: TAK-117 600 mg Fed (2*300 mg Tablets) n = 16	Part-3: TAK-117 900 mg (3*300 mg Tablets) n = 15	Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg n = 4
Value	64165.340 (77)	96293.083 (77)	81595.634 (61)	128336.896 (39)	85782.122 (85)	6547.254 (66)

Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules) vs Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets): Geometric mean ratio: 1.53 (90% CI 0.93 to 2.51)
Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets) vs Part-2: TAK-117 600 mg Fed (2*300 mg Tablets): Geometric mean ratio: 1.50 (90% CI 1.00 to 2.25)
Part-3: TAK-117 900 mg (3*300 mg Tablets) vs Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg: Geometric mean ratio: 0.08 (90% CI 0.03 to 0.18)

Population analysed: The PK-evaluable population where data at specified time points were available. The PK-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part-1: TAK-117 900 mg Capsules	0 of 19 (0%)	3 of 19 (15.8%)	Not reported
Part-1: TAK-117 900 mg Tablets	0 of 18 (0%)	5 of 18 (27.8%)	Not reported
Part-2: TAK-117 600 mg Fasted	0 of 17 (0%)	8 of 17 (47.1%)	Not reported
Part-2: TAK-117 600 mg Fed	0 of 17 (0%)	4 of 17 (23.5%)	Not reported
Part-3: TAK-117 900 mg	0 of 16 (0%)	6 of 16 (37.5%)	Not reported
Part-3: Lansoprazole 30 mg	0 of 16 (0%)	1 of 16 (6.3%)	Not reported
Part 3: Lansoprazole 30 mg + TAK-117 900 mg	0 of 16 (0%)	1 of 16 (6.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-117 and Lansoprazole in people with Neoplasm, Advanced or Metastatic, run by Millennium Pharmaceuticals, Inc..

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 5 inclusion and 6 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 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

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 8 Jan 2018). 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-117 (time frame: Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose). The study lists 4 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 NCT02625259.

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 8 Jan 2018.