A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Multiple Doses of TAK-831 in Healthy Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

The purpose of this study is to evaluate the safety and tolerability of TAK-831 when administered as multiple oral doses at escalating dose levels in healthy participants.

Key facts

Study ID

NCT03224325

Run by

Neurocrine Biosciences

People needed

50

Starts

2017-07-21

Expected to finish

2018-09-09

Last updated by the study team

2021-06-14

Who can join

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

You may qualify if…

• Has at least 45 kg weight and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m\^2), inclusive at Screening.
• The participant is a healthy male or female not of childbearing potential adult who is aged 18 to 55 years, inclusive, at the time of informed consent and first study drug dose.
• A male participant who is non-sterilized 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 90 days plus half-lives (95 days) after last study drug dose.
• A female participant with no childbearing potential, defined as a participant that has been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who is postmenopausal (defined as continuous amenorrhea of at least 12 months and follicle stimulating hormone [FSH] greater than [>] 40 international unit per liter [IU/L]).

You may not qualify if…

• Has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at Screening or Check-in.
• Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as >3 drinks per day) within 5 years before the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. (1 drink=12 ounce [oz]. beer=5 oz. wine=1.5 oz. liquor.)
• Has a QT interval with Fridericia's correction method (QTcF) >450 milliseconds (ms) (male participants) or >470 ms (female participants) or PR outside the range of 120 to 220 ms, confirmed with 1 repeat testing, at the Screening Visit or Check-in. When triplicate electrocardiogram (ECG) assessments are collected, the mean of the 3 QTcF and PR values should be used to assess this criterion.
• Has a positive test result for hepatitis B surface antigen (HBsAg), anti- human chorionic gonadotropin (HCV), or human immunodeficiency virus (HIV) antibody/antigen at Screening.
• Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days before Check-in. Cotinine test is positive at Screening or Check-in.
• Has poor peripheral venous access.
• Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days before the first dose of study medication.
• Has a Screening or Check-in abnormal (clinically significant) ECG. Entry of any participant with an abnormal (not clinically significant) ECG must be approved and documented by signature by the principal investigator or designee.
• Has a supine blood pressure outside 90 to 140 millimeter of mercury (mm Hg) for systolic and 50 to 90 mm Hg for diastolic, confirmed on repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in.
• Has a resting heart rate outside 40 to 100 beats per minute confirmed on repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in (heart rate from the ECG does not apply).
• Has a risk of suicide according to the Investigator's clinical judgment (example, per Columbia-Suicide Severity Rating Scale [C-SSRS]), or has scored "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior", if this behavior occurred in the past 2 years.
• Additional Exclusion Criteria for Cohort(s) with cerebrospinal fluid (CSF) Collection:
• Has had CSF collection performed within 30 days before Check-in.
• Has a history of clinically significant back pain and/or injury.
• Has local infection at the puncture site.
• Has thrombocytopenia or other suspected bleeding tendencies noted before procedure.
• Has developed signs and symptoms of spinal radiculopathy, including lower extremity pain and paresthesia.
• Has any focal neurological deficit that might suggest an increase in intracranial pressure.
• Has any abnormal findings on ophthalmological assessment/fundoscopy suggestive of raised intracranial pressure (that is, optic disc swelling/edema; (uncontrolled) hypertensive retinopathy).
• Suffers regularly from moderate to severe headaches requiring analgesics.
• Has lower spinal malformations (on physical examination or lumbar spine radiography), local spinal infection, or other abnormalities that would exclude lumbar puncture (LP).

Where it is running

• California Clinical Trials Medical Group/PAREXEL — Glendale, California, United States

Full record on ClinicalTrials.gov

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