Phase 1 TAK-906 Single and Multiple Ascending Dose Study in Japanese Healthy Male Participants

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-906 in Japanese Healthy Male Subjects

ClinicalTrials.gov ID

NCT03237156

Acronym / sponsor ID

TAK-906-1004

Conditions

Japanese Healthy Adult Male Participants

Keywords

Drug therapy

Phase

Phase 1

Study type

Interventional

Recruitment status

Completed

Enrolment

24 participants (actual)

Lead sponsor

TakedaIndustry (pharma, biotech, devices)

Study start

7 Aug 2017 (actual)

Primary completion

7 Oct 2017 (actual)

Study completion

7 Oct 2017 (actual)

First posted

2 Aug 2017 (actual)

Results

Posted 18 Feb 2019

Clinical summary

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

Study design

Primary purpose

Other

Allocation

Randomised

Intervention model

Parallel groups

Masking

Double blind (participant, investigator)

Number of arms

6

Who may qualify

Ages

20 to 60 years

Sex

Male only

Healthy volunteers

Accepted

Age groups

Adult

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

Interventions

Primary outcome

1. Number of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE)

   Time frame: Baseline up to Day 14

   An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment or study participation. A treatment-emergent adverse events (TEAE) is defined as an AE whose date of onset occurs on or after the start of study drug.

2. Number of Participants With Markedly Abnormal Values of Vital Signs

   Time frame: Baseline up to Day 14

   Reported data were numbers of participants who met markedly abnormal criteria of vital signs. Vital signs included body temperature, respiratory rate, blood pressure, and pulse. Vital signs collected were classified as markedly abnormal values if they met the following criteria: systolic blood pressure less than (<) 85 millimeter of mercury (mmHg) or greater than (>) 180 mmHg, diastolic blood pressure <50 mmHg or >110 mmHg, pulse <50 beats per minute (bpm) or >120 bpm, body temperature <35.6 °C or >37.7 °C.

3. Number of Participants With Markedly Abnormal Values of Clinical Laboratory Test Results

   Time frame: Baseline up to Day 14

   Reported data were numbers of participants who met markedly abnormal criteria of clinical laboratory test results. Clinical laboratory test results collected were classified as markedly abnormal values if they met the following criteria: red blood cells <0.8×lower limit of normal (LLN) or >1.2×upper limit of normal (ULN), platelets <75×10^3/μL or >600×10^3/μL, white blood cells <0.5×LLN or >1.5×ULN, protein (total) <0.8×LLN or >1.2×ULN, albumin <2.5 g/dL, blood urea nitrogen >30 mg/dL, uric acid >13.0 mg/dL, creatinine >2.0 mg/dL, total cholesterol >300 mg/dL, triglycerides >2.5×ULN, bilirubin (total) >2.0 mg/dL, Sodium <130 mEq/L or >150 mEq/L, Potassium <3.0 mEq/L or >6.0 mEq/L, Chloride <75 mEq/L or >126 mEq/L, Calcium <7.0 mg/dL or >11.5 mg/dL, Phosphorus <1.6 mg/dL or >6.2 mg/dL, alkaline phosphatase >3×ULN, aspartate aminotransferase >3×ULN, alanine aminotransferase >3×ULN, gamma-glutamyl transferase >3×ULN, glucose <50 mg/dL or >350 mg/dL, Magnesium <1.2 mg/dL or >3.0 mg/dL.

4. Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG)

   Time frame: Baseline up to Day 8

   Reported data were numbers of participants who met markedly abnormal criteria of 12-lead ECG. A standard 12-lead ECG was performed. The data collected was classified as markedly abnormal values if it met the following criteria: heart rate <50 bpm or >120 bpm, QT interval less than or equal to (<=) 50 msec or greater than or equal to (>=) 460 msec, QTcF interval <=50 msec or either of the following conditions was met: observed value >=500 msec, change from Day 1 Predose >= 30 msec and observed value >=450 msec.

5. Number of Participants With TEAEs Related to Physical Examinations

   Time frame: Baseline up to Day 14

   An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment or study participation. A treatment-emergent adverse events (TEAE) is defined as an AE whose date of onset occurs on or after the start of study drug.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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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.

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