Healthy VolunteersPhase 1NCT02396147

Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy Participants

A Phase 1 study testing TAK-385 T2 Formulation, TAK-385 T4 Formulation B and TAK-385 T4 Formulation C in people with Healthy Volunteers, run by Takeda 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

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Trial summary

The purpose of this study is to evaluate the oral bioavailability of two new tablet formulations of TAK-385 (T4 Formulation B and T4 Formulation C) under fasted and fed conditions, relative the T2 Formulation tablet; and to estimate the effect of food on the pharmacokinetics (PK) of a single oral dose of the T4… Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: TAK-385 T2 Formulation, TAK-385 T4 Formulation B and TAK-385 T4 Formulation C
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteUnited States
Study dates: Mar 2015to Jun 2015
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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Age 18 to 55 years, inclusive, at the time of consent.
Healthy adult male, as determined by a physician evaluation that includes:
Medical history (ie, no clinically significant medical conditions requiring ongoing drug therapy).
Physical examination.
Vital signs.
Electrocardiogram (ECG).

Show all 17Show fewer

Laboratory evaluation (hematology, biochemistry, and urinalysis).
No acute illness within 30 days before screening that required prescription or over-the-counter (OTC) medicines.
Weight ≥ 55 kg and body mass index (BMI) between 18.0 and 32.0 kg/m^2 inclusive, at Screening.
Nonsmoker for at least 2 years and does not use nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, or nicotine patch or gum).
Male participants, even if surgically sterilized (ie, status postvasectomy), who:
Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Suitable venous access for the study-required blood sampling.
Abstains from behavior that increases susceptibility to contract blood-borne pathogens (eg, obtaining a tattoo or participating in unsafe needle use for any purpose) during the 28 days before study entry.
In the opinion of the investigator, the participant or legal guardian is capable of understanding and complying with protocol requirements.

Who cannot join

Has any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
Has received any investigational compound within 30 days (or 5 half- lives of the compound, if longer) before check-in (Day -1).
Has received TAK-385 in a previous clinical study.
Has current or recent (within 6 months) history of gastrointestinal disease that would be expected to influence the absorption of drugs (ie, history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent heartburn, or any surgical intervention).
Is lactose intolerant.
Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within 1 year before screening or is unwilling to agree to abstain from alcohol and drugs throughout the study.

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Has a positive test result for hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody at Screening.
Has a positive urine drug result for drugs of abuse or alcohol at Screening or check-in (Day -1).
Has taken any prescription medicine or herbal preparations (eg, St. John's wort) or received any immunizations within 30 days before check-in (Day -1).
Has taken any OTC medications or vitamin supplements within 14 days before check-in (Day -1). Excluded from this list is occasional use of acetaminophen (paracetamol) ≤ 1 g/day or other medication approved by the sponsor on a case-by-case basis.
Is unwilling to agree to abstain from caffeine and food products from 72 hours before check-in (Day -1) to completion of the study.
Has a clinically significant electrocardiogram (ECG) abnormality at Screening or check-in (Day -1) or a QTc interval (by the Fridericia correction) of 450 msec or greater. The participant has a history of cardiac disease including, but not limited to, congenital long-QT syndrome, torsades de pointes or torsades de pointes risk factors (eg, cardiac insufficiency, hypokalemia, family history of long-QT syndrome, current use of Class IA [eg, quinidine or procainamide] or Class III [eg, amiodarone or sotalol] antiarrhythmic medications or other medications with known effects on QT interval).
Has abnormal laboratory values suggesting a clinically significant disease at Screening or check-in (Day -1) or has abnormalities in the following laboratory parameters: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) value >1.5 times the upper limit of normal.
Has engaged in heavy exercise (marathon running, weight lifting, etc) within 72 hours before check-in (Day -1) or is unwilling to agree to abstain from heavy exercise throughout the study.
Has known allergy to TAK-385 or its excipients.
Participants who, for any reason, are deemed by the investigator to be inappropriate for this study, including participants who are unable to communicate or to cooperate with the investigator.
Any participant who is an immediate family member, investigational site employee, or in a dependent relationship with an investigational site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Tempe, Arizona

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Randomized, Three-Way Crossover Study Evaluating the Relative Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy Subjects

Read the detailed description

The drug being tested in this study is called TAK-385. In this study, two new formulations of TAK-385 are being evaluated under fasted and fed conditions, relative to a previous formulation of TAK-385, to assess its bioavailability and how it is processed by the body. This study will look at lab results of people who take TAK-385.

The study will enroll approximately 54 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups (Arms). Participants in Arm 1 will receive TAK-385 T2 Formulation 120 mg tablet (80mg + 40mg tablets) under fasted conditions, TAK-385 T4 Formulation B 120 mg tablet under fasted conditions, and TAK-385 T4 Formulation B 120 mg tablet under fed conditions. Participants in Arm 2 will receive TAK-385 T2 Formulation 120 mg tablet (80mg + 40mg tablets) under fasted conditions, TAK-385 T4 Formulation C 120 mg tablet under fasted conditions, and TAK-385 T4 Formulation C 120 mg tablet under fed conditions. Participants in each arm will be randomized to receive study drug in one of 6 treatment sequences. Study medication will be administered as a single dose on Days 1, 11 and 21. There will be a 10-day washout period between each dose.

This single-centre trial will be conducted in the United States. The overall time to participate in this study is 51 days. Participants will make 10 visits to the clinic, including three 4-day periods of confinement to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.

Conditions: Healthy Volunteers
Being tested: TAK-385 T2 Formulation, TAK-385 T4 Formulation B, TAK-385 T4 Formulation C
Keywords: Drug therapy

What participants receive

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

TAK-385 T2 FormulationDrug
TAK-385 T2 Formulation tablets
TAK-385 T4 Formulation BDrug
TAK-385 T4 Formulation B tablets
TAK-385 T4 Formulation CDrug
TAK-385 T4 Formulation C tablets

Study groups in NCT02396147
Study group	Role	What they receive
Arm 1: T2-A + T4B-B + T4B-C	Experimental	T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose. Receives: Drug: TAK-385 T2 Formulation; Drug: TAK-385 T4 Formulation B
Arm 2: T2-A + T4C-D + T4C-E	Experimental	T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose. Receives: Drug: TAK-385 T2 Formulation; Drug: TAK-385 T4 Formulation C

What is being measured

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

Cmax: Maximum Observed Plasma Concentration for TAK-385
Measured: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose
AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose for TAK-385
Measured: Days 1, 11, and 21 predose 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-385
Measured: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose

Secondary outcomes (7)

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Measured: From Day 1 to 30 days after the last dose of study drug (Up to 51 days total)
Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant
Participants with shifts from normal at Baseline in safety laboratory values (Clinical Chemistry, Hematology and Urinalysis) collected throughout study. Low=below normal reference range, Normal=within reference range, High=above normal reference range and Abnormal=outside of normal reference range.
Measured: Baseline and Days 4, 10, 14, 20, 24 and 26
Percentage of Participants With Electrocardiogram (ECG) Parameters Abnormal and Clinically Significant
A 12-lead ECG was administered. The investigator interpreted the ECG using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant.
Measured: Days 1, 11, 21 and 26
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study.
Measured: From Day 1 to Day 26
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385
Measured: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose
Terminal Phase Elimination Half-Life (T1/2) for TAK-385
Measured: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose
Oral Clearance (CL/F) for TAK-385
Measured: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose

Timeline

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

Mar 2015Jun 2015

First posted24 Mar 2015 (estimated)
Study startMar 2015
Primary completionApr 2015
Study completionJun 2015

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 VolunteersStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
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: NCT02396147
Sponsor's protocol ID: TAK-385-1010
Other IDs: U1111-1165-3720
Status last verified: Jun 2016
First submitted: 18 Mar 2015
Last updated: 25 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Randomized, Three-Way Crossover Study Evaluating the Relative Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy Subjects
ClinicalTrials.gov ID: NCT02396147
Acronym / sponsor ID: TAK-385-1010
Conditions: Healthy Volunteers
Keywords: Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Mar 2015
Primary completion: Apr 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 24 Mar 2015 (estimated)
Results: Posted 25 Jul 2016

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1: T2-A + T4B-B + T4B-C	Experimental	Drug: TAK-385 T2 Formulation, Drug: TAK-385 T4 Formulation BT2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose.
Arm 2: T2-A + T4C-D + T4C-E	Experimental	Drug: TAK-385 T2 Formulation, Drug: TAK-385 T4 Formulation CT2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose.

Who may qualify

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

Key inclusion criteria (17 listed)

Age 18 to 55 years, inclusive, at the time of consent.
Healthy adult male, as determined by a physician evaluation that includes:
Weight ≥ 55 kg and body mass index (BMI) between 18.0 and 32.0 kg/m^2 inclusive, at Screening.
Nonsmoker for at least 2 years and does not use nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, or nicotine patch or gum).
Male participants, even if surgically sterilized (ie, status postvasectomy), who:

Key exclusion criteria (17 listed)

Has any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
Has received any investigational compound within 30 days (or 5 half- lives of the compound, if longer) before check-in (Day -1).
Has received TAK-385 in a previous clinical study.
Has current or recent (within 6 months) history of gastrointestinal disease that would be expected to influence the absorption of drugs (ie, history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent heartburn, or any surgical intervention).
Is lactose intolerant.

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-385 T2 FormulationTAK-385 T2 Formulation tablets	Drug	Arm 1: T2-A + T4B-B + T4B-C, Arm 2: T2-A + T4C-D + T4C-E
TAK-385 T4 Formulation BTAK-385 T4 Formulation B tablets	Drug	Arm 1: T2-A + T4B-B + T4B-C
TAK-385 T4 Formulation CTAK-385 T4 Formulation C tablets	Drug	Arm 2: T2-A + T4C-D + T4C-E

Primary outcome

Cmax: Maximum Observed Plasma Concentration for TAK-385
Time frame: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose
AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose for TAK-385
Time frame: Days 1, 11, and 21 predose 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-385
Time frame: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose

7 secondary outcomes

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 to 30 days after the last dose of study drug (Up to 51 days total)
Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant
Time frame: Baseline and Days 4, 10, 14, 20, 24 and 26
Percentage of Participants With Electrocardiogram (ECG) Parameters Abnormal and Clinically Significant
Time frame: Days 1, 11, 21 and 26
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Time frame: From Day 1 to Day 26
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385
Time frame: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose
Terminal Phase Elimination Half-Life (T1/2) for TAK-385
Time frame: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose
Oral Clearance (CL/F) for TAK-385
Time frame: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose

Results and safety

Results posted to the registry on 25 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: T2-A + T4B-B + T4B-C	27	27
Arm 2: T2-A + T4C-D + T4C-E	27	27

Primary outcome: Cmax: Maximum Observed Plasma Concentration for TAK-385

Time frame: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Arm 1: T2 Formulation Fasted n = 27	Arm 1: T4 Formulation B Fasted n = 26	Arm 1: T4 Formulation B Fed n = 27	Arm 2: T2 Formulation Fasted n = 27	Arm 2: T4 Formulation C Fasted n = 27	Arm 2: T4 Formulation C Fed n = 27
Value	46.7 (114.9)	42.0 (153.1)	33.0 (115.5)	52.0 (93.3)	43.5 (146.8)	41.2 (105.9)

Arm 1: T2 Formulation Fasted vs Arm 1: T4 Formulation B Fasted: Geometric Mean Ratio: 87.09 (90% CI 58.56 to 129.52)
Arm 2: T2 Formulation Fasted vs Arm 2: T4 Formulation C Fasted: Geometric Mean Ratio: 83.09 (90% CI 59.95 to 115.18)
Arm 1: T4 Formulation B Fasted vs Arm 1: T4 Formulation B Fed: Geometric Mean Ratio: 78.59 (90% CI 52.88 to 116.79)

Population analysed: Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.

Primary outcome: AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose for TAK-385

Time frame: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng•hr/mL

Measure	Arm 1: T2 Formulation Fasted n = 27	Arm 1: T4 Formulation B Fasted n = 26	Arm 1: T4 Formulation B Fed n = 27	Arm 2: T2 Formulation Fasted n = 27	Arm 2: T4 Formulation C Fasted n = 27	Arm 2: T4 Formulation C Fed n = 27
Value	447 (64.7)	440 (83.3)	350 (65.0)	532 (55.4)	415 (85.1)	386 (52.4)

Arm 1: T4 Formulation B Fasted vs Arm 2: T2 Formulation Fasted: Geometric Mean Ratio: 94.53 (90% CI 74.83 to 119.40)
Arm 2: T2 Formulation Fasted vs Arm 2: T4 Formulation C Fasted: Geometric Mean Ration: 77.99 (90% CI 64.29 to 94.61)
Arm 1: T4 Formulation B Fasted vs Arm 1: T4 Formulation B Fed: Geometric Mean Ratio: 81.08 (90% CI 64.21 to 102.37)

Population analysed: PK-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.

Primary outcome: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385

Time frame: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Arm 1: T2 Formulation Fasted n = 27	Arm 1: T4 Formulation B Fasted n = 26	Arm 1: T4 Formulation B Fed n = 27	Arm 2: T2 Formulation Fasted n = 27	Arm 2: T4 Formulation C Fasted n = 27	Arm 2: T4 Formulation C Fed n = 27
Value	476 (63.5)	467 (82.8)	372 (64.1)	563 (55.1)	440 (84.8)	409 (51.8)

Arm 1: T2 Formulation Fasted vs Arm 1: T4 Formulation B Fasted: Geometric Mean Ratio: 94.43 (90% CI 74.85 to 119.12)
Arm 2: T2 Formulation Fasted vs Arm 2: T4 Formulation C Fasted: Geometric Mean Ratio: 78.09 (90% CI 64.53 to 94.51)
Arm 1: T4 Formulation B Fasted vs Arm 1: T4 Formulation B Fed: Geometric Mean Ratio: 81.16 (90% CI 64.36 to 102.34)

Population analysed: PK-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 1 to 30 days after the last dose of study drug (Up to 51 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: T2 Formulation Fasted	0 of 27 (0%)	1 of 27 (3.7%)	Not reported
Arm 1: T4 Formulation B Fasted	0 of 27 (0%)	2 of 27 (7.4%)	Not reported
Arm 1: T4 Formulation B Fed	0 of 27 (0%)	2 of 27 (7.4%)	Not reported
Arm 2: T2 Formulation Fasted	0 of 27 (0%)	1 of 27 (3.7%)	Not reported
Arm 2: T4 Formulation C Fasted	0 of 27 (0%)	1 of 27 (3.7%)	Not reported
Arm 2: T4 Formulation C Fed	0 of 27 (0%)	2 of 27 (7.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
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 Clinical Science 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-385 T2 Formulation, TAK-385 T4 Formulation B and TAK-385 T4 Formulation C in people with Healthy Volunteers, run by Takeda 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 17 inclusion and 17 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 25 Jul 2016. 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 25 Jul 2016). 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-385 (time frame: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-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 NCT02396147.

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 25 Jul 2016.