Healthy VolunteersPhase 1NCT02847325
Study of AC0058TA in Healthy Male and Female Subjects
A Phase 1 study testing AC0058TA in people with Healthy Volunteers, run by ACEA Therapeutics, Inc. at 1 site in United States.
Trial summary
AC0058TA is a small molecule compound that potently, selectively and irreversibly inhibits Bruton's tyrosine kinase (BTK) phosphorylation and downstream signals, resulting in inhibition of inflammatory cytokine production in monocytes and inhibition of lymphocyte activation (predominantly B-cell activation) in the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AC0058TA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Apr 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, of any ethnic origin, age ≥18 and ≤65 years of age;
- BMI ≥18.5 and ≤32.0 kg/m2;
- Medical history without major pathology and determined to be in good health with no clinically significant findings as assessed by the Investigator;
- All clinical laboratory tests of blood and urine are within the normal range or show no clinically relevant deviations as judged by the Investigator;
- A female must be
- postmenopausal (ie, have spontaneous amenorrhea for ≥12 consecutive months with follicle stimulating hormone (FSH) ≥40 mIU/mL at Screening, and be of an appropriate age) or
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- surgically sterile (ie, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, tubal occlusion) for at least 90 days prior to Screening;
- Male subjects must agree to use at least 2 methods of contraception with a female partner of childbearing potential, with at least 1 method being a highly effective method of contraception (as defined in Section 5.5), to refrain from sperm donation, and to refrain from unprotected sexual intercourse with a female who is pregnant or breastfeeding during the study from the time of signing the informed consent or 10 days prior to Check-in (Day -1) until 90 days after the last administration of study medication or discontinuation;
- Able to comprehend and abide by the study restrictions, and willing to sign an Informed Consent Form (ICF)
Who cannot join
- Has a significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, immune suppressive/defective, or psychiatric disorder as determined by the Investigator;
- Has a history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
- Has a history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (a subject who has had an appendectomy or hernia repair may be enrolled in the study);
- Has a history of congenital nonhemolytic hyperbilirubinaemia (eg, Gilbert's syndrome);
- Has a history of alcoholism or drug addiction within 1 year prior to Check-in;
- Has a positive test for selected drugs of abuse at Screening (not including alcohol) or Check-in (including alcohol);
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- Has a positive hepatitis panel and/or positive human immunodeficiency virus (HIV) antibody screens;
- Has a positive pregnancy test result at Screening or Check-in (females only);
- Has clinically significant findings as determined by the Investigator (eg, medical history, 12-lead ECG, vital signs, or clinical laboratory evaluations;
- Has participated in any other investigational drug trial in which receipt of an investigational drug (new chemical entity) occurred within 5 half-lives of the respective study drug or 30 days prior to Check-in, whichever is longer;
- Has used any medications/products, including St. John's Wort, known to alter drug absorption or elimination processes within 30 days prior to Check-in, unless deemed acceptable by the Investigator;
- Has used any prescription medications/products not discussed in another exclusion criterion within 14 days prior to Check-in, unless deemed acceptable by the Investigator;
- Has used slow-release medications/products considered to still be active within 14 days prior to Check-in, unless deemed acceptable by the Investigator; 14. Has used any over-the-counter, nonprescription medications/products not discussed in another exclusion criterion (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior to Check-in, unless deemed acceptable by the Investigator;
- Has donated blood within 30 days prior to Screening, plasma within 2 weeks prior to Screening, or platelets within 6 weeks prior to Screening;
- Has received blood products within 2 months prior to Check-in;
- Has poor peripheral venous access;
- Who, in the opinion of the Investigator, should not participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Development Services
Dallas, Texas, 75247
About this study
Official title: A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single- and Multiple-Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of AC0058TA in Healthy Male and Female Subjects
AC0058TA is a small molecule compound that potently, selectively and irreversibly inhibits Bruton's tyrosine kinase (BTK) phosphorylation and downstream signals, resulting in inhibition of inflammatory cytokine production in monocytes and inhibition of lymphocyte activation (predominantly B-cell activation) in the preclinical studies. The nonclinical program has demonstrated that AC0058TA has the potential to interfere with signaling functions mediated by tyrosine kinases and may be useful for controlling excessive or aberrant T- and B-cell activation in autoimmune diseases.
As an investigational targeted therapy for RA and SLE, AC0058TA is expected to address the unmet need of this patient population, for whom there are currently no effected therapies and there is a great unmet medical need, AC0058TA may inhibit the key pathway which involves the disease process.
Read the detailed description
This is a 2-part, randomized, double-blind, placebo-controlled, single-dose-escalation (Part 1) and multiple-dose-escalation (Part 2) study to evaluate the safety, tolerability, PK, and PD of AC0058TA administered orally to healthy subjects. Part 1 of the study will also to evaluate the effect of food on the pharmacokinetics of a single oral dose of AC0058TA.
- Conditions
- Healthy Volunteers
- Being tested
- AC0058TA, Placebo capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC0058TADrug
Also called AC0058
50 mg AC0058TA 100 mg AC0058TA 200 mg AC0058TA 400 mg AC0058TA
Placebo capsulesDrug
Also called Placebo
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| AC0058TA | Experimental | Drug: 50 mg AC0058TA Drug: 100 mg AC0058TA Drug: 200 mg AC0058TA Drug: 400 mg AC0058TA Receives: Drug: AC0058TA |
| Placebo capsules | Placebo comparator | Drug: Placebo capsules Receives: Drug: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single and multiple oral doses of AC0058TA determined by adverse events
Frequency and severity of AEs and serious AEs
Measured: within 6 days after single dose in part 1, within 14 days after last dose in part 2.
Secondary outcomes (4)
Plasma concentrations of single dose or multiple doses of AC0058TA
Maximum observed concentration (Cmax)
Measured: within 6 days after single dose in part 1, within 14 days after last dose in part 2.
Time to maximum observed concentration (Tmax)
Time to maximum observed concentration (Tmax)
Measured: within 6 days after single dose in part 1, within 14 days after last dose in part 2.
Area under the concentration-time curve (AUC)
Area under the concentration-time curve (AUC)
Measured: within 6 days after single dose in part 1, within 14 days after last dose in part 2.
The effect of food on AUC of the single-oral-dose AC0058TA
Area under the concentration-time curve (AUC)
Measured: within 6 days after single dose in part 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionApr 2017
- Study completionApr 2017
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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACEA Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847325
- Sponsor's protocol ID
- AC00582015-101
- Status last verified
- Jan 2018
- First submitted
- 21 Jul 2016
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single- and Multiple-Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of AC0058TA in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02847325
- Acronym / sponsor ID
- AC00582015-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- ACEA Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 28 Jul 2016 (estimated)
- 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.
AC0058TA is a small molecule compound that potently, selectively and irreversibly inhibits Bruton's tyrosine kinase (BTK) phosphorylation and downstream signals, resulting in inhibition of inflammatory cytokine production in monocytes and inhibition of lymphocyte activation (predominantly B-cell activation) in the preclinical studies. The nonclinical program has demonstrated that AC0058TA has the potential to interfere with signaling functions mediated by tyrosine kinases and may be useful for controlling excessive or aberrant T- and B-cell activation in autoimmune diseases.
As an investigational targeted therapy for RA and SLE, AC0058TA is expected to address the unmet need of this patient population, for whom there are currently no effected therapies and there is a great unmet medical need, AC0058TA may inhibit the key pathway which involves the disease process.
Detailed description
This is a 2-part, randomized, double-blind, placebo-controlled, single-dose-escalation (Part 1) and multiple-dose-escalation (Part 2) study to evaluate the safety, tolerability, PK, and PD of AC0058TA administered orally to healthy subjects. Part 1 of the study will also to evaluate the effect of food on the pharmacokinetics of a single oral dose of AC0058TA.
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 |
|---|---|---|
| AC0058TA | Experimental | Drug: AC0058TADrug: 50 mg AC0058TA Drug: 100 mg AC0058TA Drug: 200 mg AC0058TA Drug: 400 mg AC0058TA |
| Placebo capsules | Placebo comparator | Drug: Placebo capsulesDrug: Placebo capsules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, of any ethnic origin, age ≥18 and ≤65 years of age;
- BMI ≥18.5 and ≤32.0 kg/m2;
- Medical history without major pathology and determined to be in good health with no clinically significant findings as assessed by the Investigator;
- All clinical laboratory tests of blood and urine are within the normal range or show no clinically relevant deviations as judged by the Investigator;
- A female must be
Key exclusion criteria (17 listed)
- Has a significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, immune suppressive/defective, or psychiatric disorder as determined by the Investigator;
- Has a history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
- Has a history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (a subject who has had an appendectomy or hernia repair may be enrolled in the study);
- Has a history of congenital nonhemolytic hyperbilirubinaemia (eg, Gilbert's syndrome);
- Has a history of alcoholism or drug addiction within 1 year prior to Check-in;
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 |
|---|---|---|
| AC0058TAAlso: AC005850 mg AC0058TA 100 mg AC0058TA 200 mg AC0058TA 400 mg AC0058TA | Drug | AC0058TA |
| Placebo capsulesAlso: PlaceboPlacebo capsules | Drug | Placebo capsules |
Primary outcome
Safety and tolerability of single and multiple oral doses of AC0058TA determined by adverse events
Time frame: within 6 days after single dose in part 1, within 14 days after last dose in part 2.
Frequency and severity of AEs and serious AEs
4 secondary outcomes
Plasma concentrations of single dose or multiple doses of AC0058TA
Time frame: within 6 days after single dose in part 1, within 14 days after last dose in part 2.
Time to maximum observed concentration (Tmax)
Time frame: within 6 days after single dose in part 1, within 14 days after last dose in part 2.
Area under the concentration-time curve (AUC)
Time frame: within 6 days after single dose in part 1, within 14 days after last dose in part 2.
The effect of food on AUC of the single-oral-dose AC0058TA
Time frame: within 6 days after single dose in part 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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 AC0058TA in people with Healthy Volunteers, run by ACEA Therapeutics, Inc. at 1 site in United States.
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 9 inclusion and 17 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: finished, as of the sponsor's last update on 28 Feb 2019. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability of single and multiple oral doses of AC0058TA determined by adverse events (time frame: within 6 days after single dose in part 1, within 14 days after last dose in part 2.). 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 28 Feb 2019.