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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
Date last updated
27/04/2023

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
6/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/11/2022
Sample size
Target
Accrual to date
Final
8
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
Randomized single ascending dose placebo controlled treatment of ACH-000029 administered orally via capsule in healthy volunteers.
Trial website
https://clinicaltrials.gov/study/NCT05363839
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05363839