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

NCT ID: NCT05363839

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-06
• Study Completion Date: 2022-11-02

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SAD Cohorts 1 to 3 - Participants Receiving ACH-000029

Each SAD cohort participant will be randomized to receive 10mg for cohort 1; up to 30mg and up to 60mg for cohorts 2 and 3 respectively dependent on dose review committee.

Group Type: EXPERIMENTAL

ACH-000029

Intervention Type: DRUG

ACH-000029 will be administered orally via a capsule.

SAD Cohorts 1 to 3 - Participants Receiving Placebo

Each SAD cohort participant will be randomized to receive placebo on a ratio of 3:1 (active: placebo).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered orally via a capsule.

Interventions

ACH-000029

ACH-000029 will be administered orally via a capsule.

Intervention Type: DRUG

Placebo

Placebo will be administered orally via a capsule.

Intervention Type: DRUG

Other Intervention Names

Matching Placebo

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: collaborator

Syneos Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nucleus Network Pty Ltd

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

X07-201-00001

Identifier Type: -

Identifier Source: org_study_id