Healthy VolunteersPhase 1NCT05363839
To Assess the Safety, Tolerability and Pharmacokinetics of ACH-000029 in Healthy Subjects
A Phase 1 study testing ACH-000029 in people with Healthy Volunteers, run by Syneos Health at 1 site in Australia.
Trial summary
Randomized single ascending dose placebo controlled treatment of ACH-000029 administered orally via capsule in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ACH-000029
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteAustralia
- Study dates
- 6 May 2022to 2 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or non-childbearing potential female.
- Surgically sterile male and female.
Who cannot join
- 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).
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Healthy Volunteers
- Being tested
- ACH-000029, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACH-000029Drug
ACH-000029 will be administered orally via a capsule.
PlaceboDrug
Also called Matching Placebo
Placebo will be administered orally via a capsule.
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohorts 1 to 3 - Participants Receiving ACH-000029 | Experimental | 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. Receives: Drug: ACH-000029 |
| SAD Cohorts 1 to 3 - Participants Receiving Placebo | Placebo comparator | Each SAD cohort participant will be randomized to receive placebo on a ratio of 3:1 (active: placebo). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Maximum change in timepoint-matched systolic blood pressure and diastolic blood pressure.
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Maximum change in timepoint-matched resting heart rate.
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Hemoglobin & mean corpuscular hemoglobin concentration)
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Hematocrit)
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Mean corpuscular volume)
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (RBC count)
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (WBC count (absolute and differential))
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Platelets)
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Mean platelet volume)
Measured: 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)
Measured: 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)
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Albumin)
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Glomerular filtration rate)
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Globulin)
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Total bilirubin)
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal clinical laboratory tests (Total protein)
Measured: 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.
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal Urinalysis (Bilirubin, blood, glucose, ketones, nitrites, protein)
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal Urinalysis (Leukocyte esterase)
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal Urinalysis (Microscopic analysis)
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal Urinalysis (pH)
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of abnormal Urinalysis (Specific gravity)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of Physical examinations (height)
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of Physical examinations (weight)
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Assessment of Physical examinations (BMI)
Measured: 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.
Measured: 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.
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
12-lead ECG assessment of PR interval
Change in electrocardiograms
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Screening (Days -28 to Day -2) to end of treatment Day 7
Pharmacokinetic assessment 1
Peak Plasma Concentration (Cmax)
Measured: Day 1 to end of treatment Day 7
Pharmacokinetic assessment 2
Time of peak plasma concentration (Tmax)
Measured: 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)
Measured: Day 1 to end of treatment Day 7
Pharmacokinetic assessment 4
Area under the concentration-time curve from zero to infinity (AUC∞)
Measured: Day 1 to end of treatment Day 7
Pharmacokinetic assessment 5
Apparent clearance of the drug normalized to body weight (CL/F)
Measured: Day 1 to end of treatment Day 7
Pharmacokinetic assessment 6
Apparent clearance of the drug normalized to body weight (CL/F)
Measured: Day 1 to end of treatment Day 7
Pharmacokinetic assessment 7
Terminal-phase elimination half-life (t1/2,z)
Measured: Day 1 to end of treatment Day 7
Pharmacokinetic assessment 8
Cmax normalized to dose (Cmax/Dose)
Measured: Day 1 to end of treatment Day 7
Pharmacokinetic assessment 9
Cmax normalized to dose (Cmax/Dose)
Measured: Day 1 to end of treatment Day 7
Pharmacokinetic assessment 10
AUCt normalized to dose (AUCt/Dose)
Measured: Day 1 to end of treatment Day 7
Pharmacokinetic assessment 11
AUC∞ normalized to dose (AUC∞/Dose)
Measured: Day 1 to end of treatment Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start6 May 2022
- Primary completion2 Nov 2022
- Study completion2 Nov 2022
Why it stopped: Based on the unblinded clinical data, the trial was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneos Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363839
- Sponsor's protocol ID
- X07-201-00001
- Status last verified
- Jan 2023
- First submitted
- 1 Mar 2022
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05363839
- Acronym / sponsor ID
- X07-201-00001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on the unblinded clinical data, the trial was terminated.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Syneos HealthUniversity, hospital or other
- Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Study start
- 6 May 2022 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAD Cohorts 1 to 3 - Participants Receiving ACH-000029 | Experimental | Drug: ACH-000029Each 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. |
| SAD Cohorts 1 to 3 - Participants Receiving Placebo | Placebo comparator | Drug: PlaceboEach SAD cohort participant will be randomized to receive placebo on a ratio of 3:1 (active: placebo). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male or non-childbearing potential female.
- Surgically sterile male and female.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACH-000029ACH-000029 will be administered orally via a capsule. | Drug | SAD Cohorts 1 to 3 - Participants Receiving ACH-000029 |
| PlaceboAlso: Matching PlaceboPlacebo will be administered orally via a capsule. | Drug | SAD Cohorts 1 to 3 - Participants Receiving Placebo |
Primary outcome
Number (%) of subjects experiencing orthostatic hypotension at any timepoint
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Orthostatic assessment will be with the criteria ≥ 20 mmHg decrease in SBP and a > 25 bpm increase in HR from supine to standing.
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
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Blood sample assessments will include activated partial thromboplastin time, prothrombin time-international normalized ratio.
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)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Temperature will be assessed after subject has been in supine position for at least 3 minutes.
Assessment of abnormal Vital signs (respiratory rate)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Respiratory rate will be assessed after subject has been in supine position for at least 3 minutes.
Assessment of abnormal Vital signs (blood pressure)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Blood pressure will be assessed in supine and standing positions in each position for at least 3 minutes.
Assessment of abnormal Vital signs (heart rate)
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Heart rate will be assessed in supine and standing positions in each position for at least 3 minutes.
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
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Subjects will be visually assessed for any abnormalities with head, eyes, ears, nose and throat; thorax; abdomen; urogenital; skin and mucosae.
Assessment of Neurological examinations
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Subjects will be assessed for any abnormalities and evaluated for mental status, cranial nerves, motor system, reflexes, sensory system, coordination and station and gait.
12-lead ECG assessment of PR interval
Time frame: Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7
Change in electrocardiograms
12-lead ECG assessment of QRS duration
Time frame: Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7
Change in electrocardiograms
12-lead ECG assessment of QT interval
Time frame: Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7
Change in electrocardiograms
12-lead ECG assessment of QTc
Time frame: Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7
Change in electrocardiograms
C-SSRS
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Subjects will be interviewed to capture the occurrence, severity and frequency of suicide-related thoughts and behaviors.
Monitoring of adverse events
Time frame: Screening (Days -28 to Day -2) to end of treatment Day 7
Any untoward medical occurrence in a subject, whether considered related to the treatment or not.
Pharmacokinetic assessment 1
Time frame: Day 1 to end of treatment Day 7
Peak Plasma Concentration (Cmax)
Pharmacokinetic assessment 2
Time frame: Day 1 to end of treatment Day 7
Time of peak plasma concentration (Tmax)
Pharmacokinetic assessment 3
Time frame: Day 1 to end of treatment Day 7
Area under the concentration-time curve calculated to the last observable concentration at time (AUCt)
Pharmacokinetic assessment 4
Time frame: Day 1 to end of treatment Day 7
Area under the concentration-time curve from zero to infinity (AUC∞)
Pharmacokinetic assessment 5
Time frame: Day 1 to end of treatment Day 7
Apparent clearance of the drug normalized to body weight (CL/F)
Pharmacokinetic assessment 6
Time frame: Day 1 to end of treatment Day 7
Apparent clearance of the drug normalized to body weight (CL/F)
Pharmacokinetic assessment 7
Time frame: Day 1 to end of treatment Day 7
Terminal-phase elimination half-life (t1/2,z)
Pharmacokinetic assessment 8
Time frame: Day 1 to end of treatment Day 7
Cmax normalized to dose (Cmax/Dose)
Pharmacokinetic assessment 9
Time frame: Day 1 to end of treatment Day 7
Cmax normalized to dose (Cmax/Dose)
Pharmacokinetic assessment 10
Time frame: Day 1 to end of treatment Day 7
AUCt normalized to dose (AUCt/Dose)
Pharmacokinetic assessment 11
Time frame: Day 1 to end of treatment Day 7
AUC∞ normalized to dose (AUC∞/Dose)
Results and safety
The study was stopped early (reason given: Based on the unblinded clinical data, the trial was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACH-000029 in people with Healthy Volunteers, run by Syneos Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Based on the unblinded clinical data, the trial was terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number (%) of subjects experiencing orthostatic hypotension at any timepoint (time frame: Screening (Days -28 to Day -2) to end of treatment Day 7). The study lists 49 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.