Status:
TERMINATED
To Assess the Safety, Tolerability and Pharmacokinetics of ACH-000029 in Healthy Subjects
Lead Sponsor:
Syneos Health
Collaborating Sponsors:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Randomized single ascending dose placebo controlled treatment of ACH-000029 administered orally via capsule in healthy volunteers.
Detailed Description
This study will be conducted in up to 3 dosing groups of 8 total subjects each. The purpose of this trial is to determine the safety and tolerability of a single dose of ACH-000029 or placebo.
Eligibility Criteria
Inclusion
- Healthy male or non-childbearing potential female.
- Surgically sterile male and female.
Exclusion
- Breastfeeding female subjects.
- Clinical abnormal past medical history.
- History of drug and/or alcohol abuse within 2 years prior to screening.
- History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen and/or anti-hepatitis C virus antibodies, or human immunodeficiency virus (HIV) antibodies.
- History of any significant drug allergy or known or suspected hypersensitivity.
- A positive urine or breath alcohol test and/or urine drug screen for substances of abuse at screening or upon admission to the trial site (Day -1).
- Subjects having taken an investigational drug within 30 days prior to screening or a biological investigational product within 30 days or 5 half-lives (whichever is longer) preceding screening, except the last dose of severe acute respiratory syndrome coronavirus (SARS-CoV-2 \[COVID-19\]) vaccine, which must be administered at least 7 days prior to screening.
- Any history of significant bleeding or hemorrhagic tendencies.
- Any history of difficulty in donating blood.
- The donation of blood or plasma within 30 days prior to the first dose of IMP.
- Use of prescription, over-the-counter, or herbal medications or vitamin supplements within 14 days prior to the first dose of IMP and oral antibiotics within 30 days prior to the first dose of IMP.
- Use of tobacco products or daily exposure to second-hand smoke within 2 months prior to the screening visit.
- Presenting with, or having a history of, uncontrolled hypertension (SBP \> 140 mmHg or DBP \> 90 mmHg) or symptomatic hypotension, or orthostatic hypotension, which is defined as a decrease of ≥ 30 mmHg in SBP or a decrease of ≥ 20 mmHg in DBP after at least 3 minutes of standing compared with the previous supine BP, OR development of symptoms.
- Supine HR, after resting for at least 3 minutes, outside the range of 50 to 90 bpm.
- Abnormal ECG findings at screening or check-in.
- History of unexplained syncope, where orthostatic likely event.
- Personal or family history of sudden death or long QT syndrome.
- History of serious mental disorders that, in the opinion of the investigator, would exclude the subject from participating in this trial.
- No permanent place of residence.
- Subjects with active suicidal ideation prior to dosing.
Key Trial Info
Start Date :
May 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05363839
Start Date
May 6 2022
End Date
November 2 2022
Last Update
April 27 2023
Active Locations (1)
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1
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia, 3004