Single-Dose Phase 1 Study of TAK-792
- Conditions
- Healthy Adult Male Participants
- Registration Number
- JPRN-jRCT2080222845
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 103
1.In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
2.The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
3.The participant is a healthy male of Japanese descent (born to Japanese parents and grandparents) or Caucasian descent (born to Caucasian parents and grandparents).
4.The participant is aged 20 to 45 years, inclusive, at the time of informed consent.
5.The participant weighs at least 50 kg and has a body mass index (BMI) between 18.5 and 25.0 kg/m^2 for Japanese, BMI between 18.5 and 30.0 kg/m^2 for Caucasian, inclusive at Screening and Check-in (Day -1).
6.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.
1.The participant has received any investigational compound within 16 weeks (112 days) prior to the dose of study medication.
2.The participant is an immediate family member, study site employee, or in a dependant 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.
3.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.
4.The participant has a positive urine drug result for drugs of abuse at Screening.
5.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.
6.Participant has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products table.
7.The participant intends to donate sperm during the course of this study or for 12 weeks thereafter.
8.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.
9.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]).
10.Participant has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
11.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.
12.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.
13.The participant has poor peripheral venous access.
14.The participant has undergone whole blood collection of at least 200 mL within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of study drug administration.
15.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.
16.The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of study drug administration.
17.Participant has a Screening abnormal (clinically significant) ECG.
18.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) >1.5 the upper limits of normal.
19.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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of participants who experience at least 1 treatment-emergent adverse event<br>Timeframe; Up to Day 8<br>An adverse event is defined as any untoward or unintended sign, symptom, or illness that occurs with administration of a pharmaceutical regardless of whether it is causally related to the pharmaceutical.
- Secondary Outcome Measures
Name Time Method AUC(0-96), AUC(0-tlqc), Tmax, Cmax for TAK-792<br>Timeframe; Up to 96 Hours<br>AUC(0-96): Area under the plasma concentration-time curve form 0 to 96 hours postdose of TAK-792<br>AUC(0-tlqc): Area under the plasma concentration-time curve from Time 0 to Time of the Last Quantifiable Concentration<br>Tmax: Time to reach the maximum plasma concentration<br>Cmax: Maximum observed plasma concentration