TerminatedNCT05363839Updated Apr 27, 2023

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

A Phase 1 interventional study of ACH-000029 and Placebo in Healthy Volunteers, sponsored by Syneos Health. Terminated at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-27.

Sponsored by Syneos Health · Phase 1, Interventional, and Treatment

Why this study was terminated

Based on the unblinded clinical data, the trial was terminated.

Phase: Phase 1
Study type: Interventional
Enrollment: 8
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

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

Read the 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 studied

Healthy Volunteers

In context

Lead sponsor

Syneos Health is the lead sponsor of 22 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy male or non-childbearing potential female.
Surgically sterile male and female.

Exclusion criteria

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 8 participants (actual)

Study arms

Experimental
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.
Drug: ACH-000029
Placebo comparator
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).
Drug: Placebo

Interventions

DrugACH-000029
ACH-000029 will be administered orally via a capsule.
DrugPlacebo
Placebo will be administered orally via a capsule.
Also known as: Matching Placebo

What researchers measure

Primary outcomes

Number (%) of subjects experiencing orthostatic hypotension at any timepoint
Orthostatic assessment will be with the criteria ≥ 20 mmHg decrease in SBP and a \> 25 bpm increase in HR from supine to standing.
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Maximum change in timepoint-matched systolic blood pressure and diastolic blood pressure.
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Maximum change in timepoint-matched resting heart rate.
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Hemoglobin & mean corpuscular hemoglobin concentration)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Hematocrit)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Mean corpuscular volume)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (RBC count)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (WBC count (absolute and differential))
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Platelets)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Mean platelet volume)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Anion gap, bicarbonate, calcium, chloride, cholesterol, glucose, magnesium, potassium, sodium, creatinine, uric acid, triglycerides, urea)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Lactate Dehydrogenase (LDH), Alanine Transaminase (ALT), gamma-glutamyl transferase (GGT), Alkaline phosphatase (ALP) , aspartate aminotransferase (AST), phosphatase, creatinine phosphokinase)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Albumin)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Glomerular filtration rate)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Globulin)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Total bilirubin)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Total protein)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Coagulation
Blood sample assessments will include activated partial thromboplastin time, prothrombin time-international normalized ratio.
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal Urinalysis (Bilirubin, blood, glucose, ketones, nitrites, protein)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal Urinalysis (Leukocyte esterase)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal Urinalysis (Microscopic analysis)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal Urinalysis (pH)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal Urinalysis (Specific gravity)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal Vital signs (temperature)
Temperature will be assessed after subject has been in supine position for at least 3 minutes.
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal Vital signs (respiratory rate)
Respiratory rate will be assessed after subject has been in supine position for at least 3 minutes.
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal Vital signs (blood pressure)
Blood pressure will be assessed in supine and standing positions in each position for at least 3 minutes.
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal Vital signs (heart rate)
Heart rate will be assessed in supine and standing positions in each position for at least 3 minutes.
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of Physical examinations (height)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of Physical examinations (weight)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of Physical examinations (BMI)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of Physical examinations
Subjects will be visually assessed for any abnormalities with head, eyes, ears, nose and throat; thorax; abdomen; urogenital; skin and mucosae.
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of Neurological examinations
Subjects will be assessed for any abnormalities and evaluated for mental status, cranial nerves, motor system, reflexes, sensory system, coordination and station and gait.
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
12-lead ECG assessment of PR interval
Change in electrocardiograms
Time frame: Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7
12-lead ECG assessment of QRS duration
Change in electrocardiograms
Time frame: Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7
12-lead ECG assessment of QT interval
Change in electrocardiograms
Time frame: Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7
12-lead ECG assessment of QTc
Change in electrocardiograms
Time frame: Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7
C-SSRS
Subjects will be interviewed to capture the occurrence, severity and frequency of suicide-related thoughts and behaviors.
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Monitoring of adverse events
Any untoward medical occurrence in a subject, whether considered related to the treatment or not.
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Pharmacokinetic assessment 1
Peak Plasma Concentration (Cmax)
Time frame: Day 1 to end of treatment Day 7
Pharmacokinetic assessment 2
Time of peak plasma concentration (Tmax)
Time frame: Day 1 to end of treatment Day 7
Pharmacokinetic assessment 3
Area under the concentration-time curve calculated to the last observable concentration at time (AUCt)
Time frame: Day 1 to end of treatment Day 7
Pharmacokinetic assessment 4
Area under the concentration-time curve from zero to infinity (AUC∞)
Time frame: Day 1 to end of treatment Day 7
Pharmacokinetic assessment 5
Apparent clearance of the drug normalized to body weight (CL/F)
Time frame: Day 1 to end of treatment Day 7
Pharmacokinetic assessment 6
Apparent clearance of the drug normalized to body weight (CL/F)
Time frame: Day 1 to end of treatment Day 7
Pharmacokinetic assessment 7
Terminal-phase elimination half-life (t1/2,z)
Time frame: Day 1 to end of treatment Day 7
Pharmacokinetic assessment 8
Cmax normalized to dose (Cmax/Dose)
Time frame: Day 1 to end of treatment Day 7
Pharmacokinetic assessment 9
Cmax normalized to dose (Cmax/Dose)
Time frame: Day 1 to end of treatment Day 7
Pharmacokinetic assessment 10
AUCt normalized to dose (AUCt/Dose)
Time frame: Day 1 to end of treatment Day 7
Pharmacokinetic assessment 11
AUC∞ normalized to dose (AUC∞/Dose)
Time frame: Day 1 to end of treatment Day 7

Study locations

1 site

Nucleus Network Pty Ltd
Melbourne, Victoria 3004, Australia

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05363839
Lead sponsor: Syneos Health
Collaborators: Otsuka Pharmaceutical Development & Commercialization, Inc.
Responsible party: Sponsor
First posted: May 6, 2022
Start date: May 6, 2022
Primary completion: Nov 2, 2022
Completion: Nov 2, 2022
Last update: Apr 27, 2023

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Syneos Health

Start the discussion