To Assess the Safety, Tolerability and Pharmacokinetics of ACH-000029 in Healthy Subjects

• Status: Not yet recruiting
• Trial end date: 2022-09-13
• Target enrollment: 0
• Participant gender: All

Summary

Randomized single ascending dose placebo controlled treatment of ACH-000029 administered orally via capsule in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Syneos Health
• Collaborator: Otsuka Pharmaceutical Development & Commercialization, Inc.

Criteria

Inclusion Criteria:

• Healthy male or non-childbearing potential female.

• Surgically sterile male and female.

Exclusion Criteria:

• 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.