Healthy Male Adults ParticipantsPhase 1NCT02448719

Single-Dose Phase 1 Study of TAK-792

A Phase 1 study testing TAK-792 30 mg, TAK-792 100 mg and TAK-792 250 mg in people with Healthy Male Adults Participants, run by Takeda at 1 site in Japan.

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 characterize the safety and tolerability profile of TAK-792 when administered as a single oral dose in healthy Japanese and Caucasian male participants. Read more about this study

Who is it for?: Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Male Adults Participants
What is being tested?: TAK-792 30 mg, TAK-792 100 mg and TAK-792 250 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 72 participants
Where: 1 siteJapan
Study dates: 27 May 2015to 28 Jan 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 20 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
The participant is a healthy male of Japanese descent (born to Japanese parents and grandparents) or Caucasian descent (born to Caucasian parents and grandparents).
The participant is aged 20 to 45 years, inclusive, at the time of informed consent.
The participant weighs at least 50 kilogram (kg) and has a body mass index (BMI) between 18.5 kilogram per square meter (kg/m^2) and 25.0 kg/m^2 for Japanese, BMI between 18.5 kg/m^2 and 30.0 kg/m^2 for Caucasian, inclusive at Screening and Day -1.
A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.

Who cannot join

The participant has received any investigational compound within 16 weeks (112 days) prior to the dose of study medication.
The participant is an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
The participant has a positive urine drug result for drugs of abuse at Screening.
The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
Participant has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products table.

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The participant intends to donate sperm during the course of this study or for 12 weeks thereafter.
Participant has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash.
Participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis frequent [more than once per week] occurrence of heartburn, or any surgical intervention [eg, cholecystectomy]).
Participant has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
Participant has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), human immunodeficiency virus (HIV) antibody/antigen, or serological reactions for syphilis at Screening.
Participant has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in Day -1. Cotinine test is positive at Screening.
The participant has poor peripheral venous access.
The participant has undergone whole blood collection of at least 200 milliliter (mL) within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of study drug administration.
The participant has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of study drug administration.
The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of study drug administration.
Participant has a Screening abnormal (clinically significant) electrocardiogram (ECG).
Participant has abnormal Screening laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than (>)1.5 the upper limits of normal.
Participant who, in the opinion of the investigator or sub-investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Kagoshima

Other trials in Japan

About this study

Official title: A Randomized, Single-Center, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose of TAK-792 in Healthy Subjects

The purpose of this study is to characterize the safety and tolerability profile of TAK-792 when administered as a single oral dose in healthy Japanese and Caucasian male participants.

Read the detailed description

This study will be double-blind and placebo-controlled to avoid subjective bias in the assessment of safety and tolerability of TAK-792. Sentinel dosing will be used in the first cohort (cohort 1) to ensure adequate safety and tolerability evaluation prior to administering TAK-792 to the remainder of participants within the cohort. The dose escalation to the next cohort for Cohorts 2 to 6 will occur after full review of safety and tolerability of the current cohort, and available pharmacokinetic data up to 24 hours in the preceding cohorts. The planned dose levels are 30, 100, 250, 500, 750 and 1250 mg, to be administered in the morning after a fast of at least 10 hours.

Conditions: Healthy Male Adults Participants
Being tested: TAK-792 30 mg, TAK-792 30 mg placebo, TAK-792 100 mg, TAK-792 100 mg placebo, TAK-792 250 mg

What participants receive

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

TAK-792 30 mgDrug
TAK-792 30 mg was administered in the morning after a fast.
TAK-792 30 mg placeboDrug
TAK-792 30 mg placebo was administered in the morning after a fast.
TAK-792 100 mgDrug
TAK-792 100 mg was administered in the morning after a fast.
TAK-792 100 mg placeboDrug
TAK-792 100 mg placebo was administered in the morning after a fast.
TAK-792 250 mgDrug
TAK-792 250 mg was administered in the morning after a fast.
TAK-792 250 mg placeboDrug
TAK-792 250 mg placebo was administered in the morning after a fast.
TAK-792 500 mgDrug
TAK-792 500 mg was administered in the morning after a fast or after breakfast.
TAK-792 500 mg placeboDrug
TAK-792 500 mg placebo was administered in the morning after a fast or after breakfast.
TAK-792 750 mgDrug
TAK-792 750 mg was administered in the morning after a fast.
TAK-792 750 mg placeboDrug
TAK-792 750 mg placebo was administered in the morning after a fast.
TAK-792 1250 mgDrug
TAK-792 1250 mg was administered in the morning after a fast.
TAK-792 1250 mg placeboDrug
TAK-792 1250 mg placebo was administered in the morning after a fast.

Study groups in NCT02448719
Study group	Role	What they receive
Cohort 1-active	Experimental	Single oral administration of TAK-792 30 milligram (mg) in Japanese participants Receives: Drug: TAK-792 30 mg
Cohort 1-placebo	Placebo comparator	Single oral administration of TAK-792 30 mg placebo in Japanese participants Receives: Drug: TAK-792 30 mg placebo
Cohort 2-active	Experimental	Single oral administration of TAK-792 100 mg in Japanese participants Receives: Drug: TAK-792 100 mg
Cohort 2-placebo	Placebo comparator	Single oral administration of TAK-792 100 mg placebo in Japanese participants Receives: Drug: TAK-792 100 mg placebo
Cohort 3-active	Experimental	Single oral administration of TAK-792 250 mg in Japanese participants Receives: Drug: TAK-792 250 mg
Cohort 3-placebo	Placebo comparator	Single oral administration of TAK-792 250 mg placebo in Japanese participants Receives: Drug: TAK-792 250 mg placebo
Cohort 4-active	Experimental	Single oral administration of TAK-792 500 mg in Japanese and Caucasian participants Receives: Drug: TAK-792 500 mg
Cohort 4-placebo	Placebo comparator	Single oral administration of TAK-792 500 mg placebo in Japanese and Caucasian participants Receives: Drug: TAK-792 500 mg placebo
Cohort 5-active	Experimental	Single oral administration of TAK-792 750 mg in Japanese and Caucasian participants Receives: Drug: TAK-792 750 mg
Cohort 5-placebo	Placebo comparator	Single oral administration of TAK-792 750 mg placebo in Japanese and Caucasian participants Receives: Drug: TAK-792 750 mg placebo
Cohort 6-active	Experimental	Single oral administration of TAK-792 1250 mg in Japanese and Caucasian participants Receives: Drug: TAK-792 1250 mg
Cohort 6-placebo	Placebo comparator	Single oral administration of TAK-792 1250 mg placebo in Japanese and Caucasian participants Receives: Drug: TAK-792 1250 mg placebo

What is being measured

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

Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Measured: Baseline up to Day 8
Number of Participants With TEAE Related to Vital Signs
Vital signs included body temperature (infra-axillary measurement), supine blood pressure (systolic and diastolic) after the participant has rested for at least 5 minutes, respiratory rate, and pulse (beats per minute [bpm]).
Measured: Baseline up to Day 5
Number of Participants With TEAE Related to Body Weight
Measured: Baseline up to Day 5
Number of Participants With TEAE Related to Electrocardiograms (ECG)
Measured: Baseline up to Day 5
Number of Participants With TEAEs Related to Laboratory Tests
Reported TEAE Related to Laboratory Tests are following; Occult blood positive, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Blood creatine phosphokinase increased, Blood glucose increased, Blood triglycerides increased, Blood urine present, Protein urine present, and White blood cell count increased.
Measured: Baseline up to Day 5
Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS)
The gastrointestinal (GI) symptoms (abdominal pain, heartburn, acid regurgitation, hunger pains, nausea, borborygmus, abdominal distension, eructation, increased flatus, constipation, diarrhoea, loose stools, hard stools, urgent need for defecation, and feeling of incomplete evacuation) using GSRS questionnaires at each assessment point. The GSRS a 15-item self-administered questionnaire that assesses the impact of GI symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to GI symptoms. TEAEs related to GSRS were reported as follows: Diarrhoea, Constipation, Faeces hard, and Faeces soft.
Measured: Baseline up to Day 5

Secondary outcomes (8)

AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II
Measured: Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II
Measured: Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II
Measured: Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose
Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II
Measured: Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose
Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose
Measured: Day 1: pre-dose and at multiple timepoints (6, 12, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose
AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2
Measured: Day -1: pre-dose and Day 1 (2.5 hours post dose)
Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2
Measured: Day -1: pre-dose and Day 1 at multiple time points (0.5, 1, 1.5, 2, 2.5, 4, 5, 6, 10, 11, 12, 24 hours; up to 24 hours) post-dose
Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2
Measured: Day -1: pre-dose and Day 1 at multiple time points (0.5, 1, 1.5, 2, 2.5, 4, 5, 6, 10, 11, 12, 24 hours; 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.

27 May 201528 Jan 2016

First posted19 May 2015 (estimated)
Study start27 May 2015
Primary completion28 Jan 2016
Study completion28 Jan 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 Healthy Male Adults ParticipantsStudies 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: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02448719
Sponsor's protocol ID: TAK-792-1001
Other IDs: U1111-1170-1571, JapicCTI-152897
Status last verified: Mar 2019
First submitted: 15 May 2015
Last updated: 19 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Single-Center, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose of TAK-792 in Healthy Subjects
ClinicalTrials.gov ID: NCT02448719
Acronym / sponsor ID: TAK-792-1001
Conditions: Healthy Male Adults Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 27 May 2015 (actual)
Primary completion: 28 Jan 2016 (actual)
Study completion: 28 Jan 2016 (actual)
First posted: 19 May 2015 (estimated)
Results: Posted 15 Feb 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 characterize the safety and tolerability profile of TAK-792 when administered as a single oral dose in healthy Japanese and Caucasian male participants.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 12

Arm	Type	Receives
Cohort 1-active	Experimental	Drug: TAK-792 30 mgSingle oral administration of TAK-792 30 milligram (mg) in Japanese participants
Cohort 1-placebo	Placebo comparator	Drug: TAK-792 30 mg placeboSingle oral administration of TAK-792 30 mg placebo in Japanese participants
Cohort 2-active	Experimental	Drug: TAK-792 100 mgSingle oral administration of TAK-792 100 mg in Japanese participants
Cohort 2-placebo	Placebo comparator	Drug: TAK-792 100 mg placeboSingle oral administration of TAK-792 100 mg placebo in Japanese participants
Cohort 3-active	Experimental	Drug: TAK-792 250 mgSingle oral administration of TAK-792 250 mg in Japanese participants
Cohort 3-placebo	Placebo comparator	Drug: TAK-792 250 mg placeboSingle oral administration of TAK-792 250 mg placebo in Japanese participants
Cohort 4-active	Experimental	Drug: TAK-792 500 mgSingle oral administration of TAK-792 500 mg in Japanese and Caucasian participants
Cohort 4-placebo	Placebo comparator	Drug: TAK-792 500 mg placeboSingle oral administration of TAK-792 500 mg placebo in Japanese and Caucasian participants
Cohort 5-active	Experimental	Drug: TAK-792 750 mgSingle oral administration of TAK-792 750 mg in Japanese and Caucasian participants
Cohort 5-placebo	Placebo comparator	Drug: TAK-792 750 mg placeboSingle oral administration of TAK-792 750 mg placebo in Japanese and Caucasian participants
Cohort 6-active	Experimental	Drug: TAK-792 1250 mgSingle oral administration of TAK-792 1250 mg in Japanese and Caucasian participants
Cohort 6-placebo	Placebo comparator	Drug: TAK-792 1250 mg placeboSingle oral administration of TAK-792 1250 mg placebo in Japanese and Caucasian participants

Who may qualify

Ages: 20 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
The participant is a healthy male of Japanese descent (born to Japanese parents and grandparents) or Caucasian descent (born to Caucasian parents and grandparents).
The participant is aged 20 to 45 years, inclusive, at the time of informed consent.
The participant weighs at least 50 kilogram (kg) and has a body mass index (BMI) between 18.5 kilogram per square meter (kg/m^2) and 25.0 kg/m^2 for Japanese, BMI between 18.5 kg/m^2 and 30.0 kg/m^2 for Caucasian, inclusive at Screening and Day -1.

Key exclusion criteria (19 listed)

The participant has received any investigational compound within 16 weeks (112 days) prior to the dose of study medication.
The participant is an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
The participant has a positive urine drug result for drugs of abuse at Screening.
The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.

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-792 30 mgTAK-792 30 mg was administered in the morning after a fast.	Drug	Cohort 1-active
TAK-792 30 mg placeboTAK-792 30 mg placebo was administered in the morning after a fast.	Drug	Cohort 1-placebo
TAK-792 100 mgTAK-792 100 mg was administered in the morning after a fast.	Drug	Cohort 2-active
TAK-792 100 mg placeboTAK-792 100 mg placebo was administered in the morning after a fast.	Drug	Cohort 2-placebo
TAK-792 250 mgTAK-792 250 mg was administered in the morning after a fast.	Drug	Cohort 3-active
TAK-792 250 mg placeboTAK-792 250 mg placebo was administered in the morning after a fast.	Drug	Cohort 3-placebo
TAK-792 500 mgTAK-792 500 mg was administered in the morning after a fast or after breakfast.	Drug	Cohort 4-active
TAK-792 500 mg placeboTAK-792 500 mg placebo was administered in the morning after a fast or after breakfast.	Drug	Cohort 4-placebo
TAK-792 750 mgTAK-792 750 mg was administered in the morning after a fast.	Drug	Cohort 5-active
TAK-792 750 mg placeboTAK-792 750 mg placebo was administered in the morning after a fast.	Drug	Cohort 5-placebo
TAK-792 1250 mgTAK-792 1250 mg was administered in the morning after a fast.	Drug	Cohort 6-active
TAK-792 1250 mg placeboTAK-792 1250 mg placebo was administered in the morning after a fast.	Drug	Cohort 6-placebo

Primary outcome

Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Time frame: Baseline up to Day 8
Number of Participants With TEAE Related to Vital Signs
Time frame: Baseline up to Day 5
Vital signs included body temperature (infra-axillary measurement), supine blood pressure (systolic and diastolic) after the participant has rested for at least 5 minutes, respiratory rate, and pulse (beats per minute [bpm]).
Number of Participants With TEAE Related to Body Weight
Time frame: Baseline up to Day 5
Number of Participants With TEAE Related to Electrocardiograms (ECG)
Time frame: Baseline up to Day 5
Number of Participants With TEAEs Related to Laboratory Tests
Time frame: Baseline up to Day 5
Reported TEAE Related to Laboratory Tests are following; Occult blood positive, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Blood creatine phosphokinase increased, Blood glucose increased, Blood triglycerides increased, Blood urine present, Protein urine present, and White blood cell count increased.
Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Baseline up to Day 5
The gastrointestinal (GI) symptoms (abdominal pain, heartburn, acid regurgitation, hunger pains, nausea, borborygmus, abdominal distension, eructation, increased flatus, constipation, diarrhoea, loose stools, hard stools, urgent need for defecation, and feeling of incomplete evacuation) using GSRS questionnaires at each assessment point. The GSRS a 15-item self-administered questionnaire that assesses the impact of GI symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to GI symptoms. TEAEs related to GSRS were reported as follows: Diarrhoea, Constipation, Faeces hard, and Faeces soft.

8 secondary outcomes

AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II
Time frame: Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II
Time frame: Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II
Time frame: Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose
Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II
Time frame: Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose
Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose
Time frame: Day 1: pre-dose and at multiple timepoints (6, 12, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose
AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2
Time frame: Day -1: pre-dose and Day 1 (2.5 hours post dose)
Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2
Time frame: Day -1: pre-dose and Day 1 at multiple time points (0.5, 1, 1.5, 2, 2.5, 4, 5, 6, 10, 11, 12, 24 hours; up to 24 hours) post-dose
Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2
Time frame: Day -1: pre-dose and Day 1 at multiple time points (0.5, 1, 1.5, 2, 2.5, 4, 5, 6, 10, 11, 12, 24 hours; up to 24 hours) post-dose

Results and safety

Results posted to the registry on 15 Feb 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
Cohort 1a-6a: Placebo	12	12
Cohort 1a: TAK-792 30 mg	6	6
Cohort 2a: TAK-792 100 mg	6	6
Cohort 3a: TAK-792 250 mg	6	6
Cohort 4a: TAK-792 500 mg	6	5
Cohort 5a: TAK-792 750 mg	6	6
Cohort 6a: TAK-792 1250 mg	6	6
Cohort 4b-6b: Placebo	6	6
Cohort 4b: TAK-792 500 mg	6	6
Cohort 5b: TAK-792 750 mg	6	6
Cohort 6b: TAK-792 1250 mg	6	6

Primary outcome: Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)

Time frame: Baseline up to Day 8. Number. Unit: percentage of participants

Measure	Cohort 1a-6a: Placebo n = 12	Cohort 1a: TAK-792 30 mg n = 6	Cohort 2a: TAK-792 100 mg n = 6	Cohort 3a: TAK-792 250 mg n = 6	Cohort 4a-1: TAK-792 500 mg n = 6	Cohort 5a-1: TAK-792 750 mg n = 6	Cohort 6a: TAK-792 1250 mg n = 6	Cohort 4a-2: Placebo n = 2	Cohort 4a-2: TAK-792 500 mg n = 5	Cohort 5a-2: Placebo n = 2	Cohort 5a-2: TAK-792 750 mg n = 6	Cohort 4b-1 - 6b: Placebo n = 6	Cohort 4b-1: TAK-792 500 mg n = 6	Cohort 5b-1: TAK-792 750 mg n = 6	Cohort 6b: TAK-792 1250 mg n = 6	Cohort 4b-2: Placebo n = 2	Cohort 4b-2: TAK-792 500 mg n = 6	Cohort 5b-2: Placebo n = 2	Cohort 5b-2: TAK-792 750 mg n = 6
Value	16.7	16.7	0.0	33.3	0.0	16.7	0.0	0.0	0.0	0.0	0.0	50.0	33.3	0.0	33.3	50.0	16.7	0.0	16.7

Population analysed: Safety analysis set included all participants who received at least 1 dose of study drug.

Primary outcome: Number of Participants With TEAE Related to Vital Signs

Time frame: Baseline up to Day 5. Count of participants. Unit: Participants

Measure	Cohort 1a-6a: Placebo n = 12	Cohort 1a: TAK-792 30 mg n = 6	Cohort 2a: TAK-792 100 mg n = 6	Cohort 3a: TAK-792 250 mg n = 6	Cohort 4a-1: TAK-792 500 mg n = 6	Cohort 5a-1: TAK-792 750 mg n = 6	Cohort 6a: TAK-792 1250 mg n = 6	Cohort 4a-2: Placebo n = 2	Cohort 4a-2: TAK-792 500 mg n = 5	Cohort 5a-2: Placebo n = 2	Cohort 5a-2: TAK-792 750 mg n = 6	Cohort 4b-1 - 6b: Placebo n = 6	Cohort 4b-1: TAK-792 500 mg n = 6	Cohort 5b-1: TAK-792 750 mg n = 6	Cohort 6b: TAK-792 1250 mg n = 6	Cohort 4b-2: Placebo n = 2	Cohort 4b-2: TAK-792 500 mg n = 6	Cohort 5b-2: Placebo n = 2	Cohort 5b-2: TAK-792 750 mg n = 6
Value	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: Safety analysis set included all participants who received at least 1 dose of study drug.

Primary outcome: Number of Participants With TEAE Related to Body Weight

Time frame: Baseline up to Day 5. Count of participants. Unit: Participants

Measure	Cohort 1a-6a: Placebo n = 12	Cohort 1a: TAK-792 30 mg n = 6	Cohort 2a: TAK-792 100 mg n = 6	Cohort 3a: TAK-792 250 mg n = 6	Cohort 4a-1: TAK-792 500 mg n = 6	Cohort 5a-1: TAK-792 750 mg n = 6	Cohort 6a: TAK-792 1250 mg n = 6	Cohort 4a-2: Placebo n = 2	Cohort 4a-2: TAK-792 500 mg n = 5	Cohort 5a-2: Placebo n = 2	Cohort 5a-2: TAK-792 750 mg n = 6	Cohort 4b-1 - 6b: Placebo n = 6	Cohort 4b-1: TAK-792 500 mg n = 6	Cohort 5b-1: TAK-792 750 mg n = 6	Cohort 6b: TAK-792 1250 mg n = 6	Cohort 4b-2: Placebo n = 2	Cohort 4b-2: TAK-792 500 mg n = 6	Cohort 5b-2: Placebo n = 2	Cohort 5b-2: TAK-792 750 mg n = 6
Value	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: Safety analysis set included all participants who received at least 1 dose of study drug.

Primary outcome: Number of Participants With TEAE Related to Electrocardiograms (ECG)

Time frame: Baseline up to Day 5. Count of participants. Unit: Participants

Measure	Cohort 1a-6a: Placebo n = 12	Cohort 1a: TAK-792 30 mg n = 6	Cohort 2a: TAK-792 100 mg n = 6	Cohort 3a: TAK-792 250 mg n = 6	Cohort 4a-1: TAK-792 500 mg n = 6	Cohort 5a-1: TAK-792 750 mg n = 6	Cohort 6a: TAK-792 1250 mg n = 6	Cohort 4a-2: Placebo n = 2	Cohort 4a-2: TAK-792 500 mg n = 5	Cohort 5a-2: Placebo n = 2	Cohort 5a-2: TAK-792 750 mg n = 6	Cohort 4b-1 - 6b: Placebo n = 6	Cohort 4b-1: TAK-792 500 mg n = 6	Cohort 5b-1: TAK-792 750 mg n = 6	Cohort 6b: TAK-792 1250 mg n = 6	Cohort 4b-2: Placebo n = 2	Cohort 4b-2: TAK-792 500 mg n = 6	Cohort 5b-2: Placebo n = 2	Cohort 5b-2: TAK-792 750 mg n = 6
Value	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: Safety analysis set included all participants who received at least 1 dose of study drug.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1a-6a: Placebo	0 of 12 (0%)	2 of 12 (16.7%)	Not reported
Cohort 1a: TAK-792 30 mg	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Cohort 2a: TAK-792 100 mg	0 of 6 (0%)	0 of 6 (0%)	Not reported
Cohort 3a: TAK-792 250 mg	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Cohort 4a-1: TAK-792 500 mg	0 of 6 (0%)	0 of 6 (0%)	Not reported
Cohort 5a-1: TAK-792 750 mg	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Cohort 6a: TAK-792 1250 mg	0 of 6 (0%)	0 of 6 (0%)	Not reported
Cohort 4a-2: Placebo	0 of 2 (0%)	0 of 2 (0%)	Not reported
Cohort 4a-2: TAK-792 500 mg	0 of 5 (0%)	0 of 5 (0%)	Not reported
Cohort 5a-2: Placebo	0 of 2 (0%)	0 of 2 (0%)	Not reported
Cohort 5a-2: TAK-792 750 mg	0 of 6 (0%)	0 of 6 (0%)	Not reported
Cohort 4b-1 - 6b: Placebo	0 of 6 (0%)	3 of 6 (50%)	Not reported
Cohort 4b-1: TAK-792 500 mg	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Cohort 5b-1: TAK-792 750 mg	0 of 6 (0%)	0 of 6 (0%)	Not reported
Cohort 6b: TAK-792 1250 mg	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Cohort 4b-2: Placebo	0 of 2 (0%)	1 of 2 (50%)	Not reported
Cohort 4b-2: TAK-792 500 mg	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Cohort 5b-2: Placebo	0 of 2 (0%)	0 of 2 (0%)	Not reported
Cohort 5b-2: TAK-792 750 mg

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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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 chair

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-792 30 mg, TAK-792 100 mg and TAK-792 250 mg in people with Healthy Male Adults Participants, run by Takeda at 1 site in Japan.

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 6 inclusion and 19 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 19 Mar 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 Japan. 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. Some participants in this study may receive a placebo. 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 15 Feb 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?

Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) (time frame: Baseline up to Day 8). The study lists 6 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 NCT02448719.

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 19 Mar 2019.