Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Participants

Takeda36 enrolled

Overview

The purpose of this study is to evaluate the safety and tolerability of single oral doses of TAK-828 in healthy non-Japanese and Japanese participants.

The drug being tested in this study is called TAK-828. TAK-828 is being tested to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single oral doses of TAK-828 in healthy non-Japanese and Japanese participants. The study enrolled 36 healthy participants. An interleaving crossover design with placebo substitution was used for Cohorts 1 and 2, and a crossover design was used in Cohort 3. Each cohort consisted of 12 participants, and participants were randomized to treatment sequence to receive TAK-828 or placebo after undergoing a fasting stage of at least 8 hours through intervention periods 1-4 for Cohorts 1 and 2 and through intervention periods 1 - 3 for Cohort 3. The assigned treatment sequence will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). An additional interventional period 5 (fed state) is planned to be conducted in either cohort 1 or 2, based on the dose of TAK-828 that will be chosen to be studied under fed conditions. Cohorts 1 and 2 were conducted in non-Japanese participants and Cohort 3 in Japanese participants. This multi-center trial was conducted in the United States. Participants remained confined to the study site from check-in (Day -1) through Day 4 of each intervention period and returned 7 to 10 days after last dose of study drug for a follow-up assessment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Dose Finding Study

Interventions

TAK-828DRUG

TAK-828 oral solution

PlaceboDRUG

TAK-828 placebo-matching oral solution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: - 1. Is a healthy male and female (non-child bearing potential) participants. 2. Cohorts 1 and 2: non-Japanese participants aged 18 to 55 years, inclusive, with body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m\^ 2), inclusive, and body weight greater than or equal (\>=) 50 kilograms (kg). 3. Cohort 3: Japanese participants (born to Japanese parents and grandparents) aged 20 to 55 years, inclusive, with BMI of 18.5 to 25 kg/m\^ 2, inclusive, and body weight \>= 45 kg. Exclusion Criteria: - 1\. Has used prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to Check-in (Day -1). Herbal supplements and hormone replacement therapy (HRT) must be discontinued 28 days prior to Check-in (Day -1). As an exception, acetaminophen may be used at doses of less than equal to (\<=) 1 gram per day (g/day). Limited use of nonprescription medications that are not believed to affect participant safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.

Locations (2)

Unnamed facility

Baltimore, Maryland, United States

Unnamed facility

Austin, Texas, United States

Outcomes

Primary Outcomes

Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event (TEAE)

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

Time frame: Day 1 up to 30 days after last dose of study drug (up to 85 days)

Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)

Time frame: Day 1 up to 30 days after last dose of study drug (up to 85 days)

Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose

Hematology and Chemistry values that met the following criteria were considered to be markedly abnormal: Erythrocytes, Hematocrit and Hemoglobin \<0.8\*Lower Limit of Normal (LLN) or \>1.2\*Upper Limit of Normal ULN.; Leukocytes \<0.5\*LLN or \>1.5\*ULN; Platelet \<75 or \>600 10\^9/liter (L). Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase \>3\*ULN; Albumin \<25 g/L; Bilirubin \> 34.2 umol/L; Blood Urea Nitrogen \>10.7 mmol/L; Chloride \<75 or \>126 mmol/L; Creatinine \>177 umol/L; Direct Bilirubin \>2\*ULN; Glucose \<2.8 or \>19.4 mmol/L; Potassium \<3.0 or \>6.0 mmol/L; Protein \<0.8\*LLN or \>1.2\*ULN; Sodium \<130 or \>150 mmol/L.

Time frame: Day 1 up to 7 days after last dose of study drug (up to 52 days)

Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose

Vital signs measurements that met the following criteria were considered to be markedly abnormal: Systolic Blood Pressure (SBP) \<85 mmHg or \>180 mmHg supine laying face upward) or standing; Diastolic Blood Pressure (DBP) \<50 mmHg or \>110 mmHg supine or standing; Pulse Rate (PR) \<50 beats/minute (bpm) or \>120 bpm supine or standing; Temperature \<35.6 degrees Celsius (C) or \>37.7 degrees C.