A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of TAK-828 Escalating Multiple-Doses in Healthy Participants

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT02817516

Run by

Takeda

People needed

24

Starts

2016-06-30

Expected to finish

2016-08-22

Last updated by the study team

2019-07-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• For Parts 1 and 2, any participant who meets any of the following criteria will not qualify for entry into the study:
• The participant received any investigational compound within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug.
• The participant used prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) before 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 or equal to (<=) 1 gram/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.
• The participant is an immediate family member or study-site employee or is in a dependent relationship with a study-site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
• The participant has a history or presence of any disease or condition (or there is any finding upon review of the participant's medical history, physical examination, or clinical laboratory tests giving reasonable suspicion of a disease) that could interfere with study participation or safety, contraindicate taking TAK-828 or a similar drug in the same class, or potentially confound the study results (example, history or presence of clinically significant neurologic, cardiovascular, pulmonary, hepatic, hematologic, renal, immunologic, metabolic, musculoskeletal, gastrointestinal, endocrine, or psychiatric disease). It is the responsibility of the investigator to assess the clinical significance; however, consultation with the Takeda medical monitor may be warranted.
• The participant has a known hypersensitivity to any component of the formulation of TAK-828.
• The participant has an active infection at Screening.
• The participant has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at Screening or Check-in (Day -1).
• The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year, or the participant drinks 7 or more drinks/week for females or 14 or more drinks/week for males (1 drink=5 ounces [150 milliliter {mL}] of wine, 12 ounces [360 mL] of beer, or 1.5 ounces [45 mL] of hard liquor) within 6 months before the Screening visit or is unwilling to abstain from alcohol and drugs throughout the study.
• The participant is taking or took any excluded medication, supplements, or food products during the time periods listed in the Prohibited Medications, Foods, and Products table
• If male, the participant intends to donate sperm during the course of this study or for 14 weeks after the last dose of study drug.
• The participant has any condition possibly affecting drug absorption (example, gastrectomy).
• The participant has a history of cancer, except basal cell carcinoma that has been in remission for at least 5 years before Screening.
• The participant has a positive test result for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at Screening or has a known history of human immunodeficiency virus (HIV) infection.
• The participant 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) or cotinine test is positive at Screening or Check-in (Day -1).
• The participant has poor peripheral venous access.
• The participant donated or lost 450 mL or more of his or her blood volume (including plasmapheresis) or had a transfusion of any blood product within 30 days prior to Day 1.
• The participant has a Screening or Check-in (Day -1) abnormal (clinically significant) ECG. Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature of the principal investigator or medically qualified subinvestigator.
• The participant has abnormal Screening or Day -1 laboratory values that suggest a clinically significant underlying disease or the participant has the following laboratory abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN).
• The participant has a creatine kinase isoenzyme MB (CK-MB) or cardiac troponin above the ULN at Screening or Day -1.
• If female, the participant is of childbearing potential (example, premenopausal, not sterilized).

Where it is running

• Study site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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