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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05363839




Registration number
NCT05363839
Ethics application status
Date submitted
1/03/2022
Date registered
6/05/2022

Titles & IDs
Public title
To Assess the Safety, Tolerability and Pharmacokinetics of ACH-000029 in Healthy Subjects
Scientific title
A Phase 1, Single-center, Placebo-controlled, Double-blind, Randomized Trial to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of ACH-000029 in Healthy Subjects
Secondary ID [1] 0 0
X07-201-00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ACH-000029
Treatment: Drugs - Placebo

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.

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).


Treatment: Drugs: ACH-000029
ACH-000029 will be administered orally via a capsule.

Treatment: Drugs: Placebo
Placebo will be administered orally via a capsule.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number (%) of subjects experiencing orthostatic hypotension at any timepoint
Timepoint [1] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [2] 0 0
Maximum change in timepoint-matched systolic blood pressure and diastolic blood pressure.
Timepoint [2] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [3] 0 0
Maximum change in timepoint-matched resting heart rate.
Timepoint [3] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [4] 0 0
Assessment of abnormal clinical laboratory tests (Hemoglobin & mean corpuscular hemoglobin concentration)
Timepoint [4] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [5] 0 0
Assessment of abnormal clinical laboratory tests (Hematocrit)
Timepoint [5] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [6] 0 0
Assessment of abnormal clinical laboratory tests (Mean corpuscular volume)
Timepoint [6] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [7] 0 0
Assessment of abnormal clinical laboratory tests (RBC count)
Timepoint [7] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [8] 0 0
Assessment of abnormal clinical laboratory tests (WBC count (absolute and differential))
Timepoint [8] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [9] 0 0
Assessment of abnormal clinical laboratory tests (Platelets)
Timepoint [9] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [10] 0 0
Assessment of abnormal clinical laboratory tests (Mean platelet volume)
Timepoint [10] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [11] 0 0
Assessment of abnormal clinical laboratory tests (Anion gap, bicarbonate, calcium, chloride, cholesterol, glucose, magnesium, potassium, sodium, creatinine, uric acid, triglycerides, urea)
Timepoint [11] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [12] 0 0
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)
Timepoint [12] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [13] 0 0
Assessment of abnormal clinical laboratory tests (Albumin)
Timepoint [13] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [14] 0 0
Assessment of abnormal clinical laboratory tests (Glomerular filtration rate)
Timepoint [14] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [15] 0 0
Assessment of abnormal clinical laboratory tests (Globulin)
Timepoint [15] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [16] 0 0
Assessment of abnormal clinical laboratory tests (Total bilirubin)
Timepoint [16] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [17] 0 0
Assessment of abnormal clinical laboratory tests (Total protein)
Timepoint [17] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [18] 0 0
Coagulation
Timepoint [18] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [19] 0 0
Assessment of abnormal Urinalysis (Bilirubin, blood, glucose, ketones, nitrites, protein)
Timepoint [19] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [20] 0 0
Assessment of abnormal Urinalysis (Leukocyte esterase)
Timepoint [20] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [21] 0 0
Assessment of abnormal Urinalysis (Microscopic analysis)
Timepoint [21] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [22] 0 0
Assessment of abnormal Urinalysis (pH)
Timepoint [22] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [23] 0 0
Assessment of abnormal Urinalysis (Specific gravity)
Timepoint [23] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [24] 0 0
Assessment of abnormal Vital signs (temperature)
Timepoint [24] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [25] 0 0
Assessment of abnormal Vital signs (respiratory rate)
Timepoint [25] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [26] 0 0
Assessment of abnormal Vital signs (blood pressure)
Timepoint [26] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [27] 0 0
Assessment of abnormal Vital signs (heart rate)
Timepoint [27] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [28] 0 0
Assessment of Physical examinations (height)
Timepoint [28] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [29] 0 0
Assessment of Physical examinations (weight)
Timepoint [29] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [30] 0 0
Assessment of Physical examinations (BMI)
Timepoint [30] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [31] 0 0
Assessment of Physical examinations
Timepoint [31] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [32] 0 0
Assessment of Neurological examinations
Timepoint [32] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [33] 0 0
12-lead ECG assessment of PR interval
Timepoint [33] 0 0
Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7
Primary outcome [34] 0 0
12-lead ECG assessment of QRS duration
Timepoint [34] 0 0
Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7
Primary outcome [35] 0 0
12-lead ECG assessment of QT interval
Timepoint [35] 0 0
Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7
Primary outcome [36] 0 0
12-lead ECG assessment of QTc
Timepoint [36] 0 0
Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7
Primary outcome [37] 0 0
C-SSRS
Timepoint [37] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [38] 0 0
Monitoring of adverse events
Timepoint [38] 0 0
Screening (Days -28 to Day -2) to end of treatment Day 7
Primary outcome [39] 0 0
Pharmacokinetic assessment 1
Timepoint [39] 0 0
Day 1 to end of treatment Day 7
Primary outcome [40] 0 0
Pharmacokinetic assessment 2
Timepoint [40] 0 0
Day 1 to end of treatment Day 7
Primary outcome [41] 0 0
Pharmacokinetic assessment 3
Timepoint [41] 0 0
Day 1 to end of treatment Day 7
Primary outcome [42] 0 0
Pharmacokinetic assessment 4
Timepoint [42] 0 0
Day 1 to end of treatment Day 7
Primary outcome [43] 0 0
Pharmacokinetic assessment 5
Timepoint [43] 0 0
Day 1 to end of treatment Day 7
Primary outcome [44] 0 0
Pharmacokinetic assessment 6
Timepoint [44] 0 0
Day 1 to end of treatment Day 7
Primary outcome [45] 0 0
Pharmacokinetic assessment 7
Timepoint [45] 0 0
Day 1 to end of treatment Day 7
Primary outcome [46] 0 0
Pharmacokinetic assessment 8
Timepoint [46] 0 0
Day 1 to end of treatment Day 7
Primary outcome [47] 0 0
Pharmacokinetic assessment 9
Timepoint [47] 0 0
Day 1 to end of treatment Day 7
Primary outcome [48] 0 0
Pharmacokinetic assessment 10
Timepoint [48] 0 0
Day 1 to end of treatment Day 7
Primary outcome [49] 0 0
Pharmacokinetic assessment 11
Timepoint [49] 0 0
Day 1 to end of treatment Day 7

Eligibility
Key inclusion criteria
* Healthy male or non-childbearing potential female.
* Surgically sterile male and female.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Syneos Health
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Otsuka Pharmaceutical Development & Commercialization, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.