HealthyPhase 1NCT03250598
Study to Evaluate the Pharmacokinetics, Safety, and QTc Effect of AG-348 in Healthy Subjects of Japanese Origin and Non-Asian Origin
A Phase 1 study testing AG-348 in people with Healthy and Japanese, run by Agios Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this Phase I, single-dose, open-label trial is to evaluate the pharmacokinetics, safety, and effect on QTc interval of AG-348 in healthy, adult Japanese and Non-Asian subjects. The study plans to evaluate 3 cohorts of a single oral dose of AG-348 in Japanese and Non-Asian subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- AG-348
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2017to 9 Oct 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be a male or female aged 18 to 55 years, inclusive.
- Have a body mass index (BMI) of ≥ 18.5 to ≤ 29.0 kg/m2 at Screening.
- Be healthy overall with no clinically significant medical abnormalities, as determined by the Investigator through evaluation of the subject's medical history and Screening vital signs, ECG, physical examination, and laboratory assessments.
- Applicable to Japanese Subjects Only: Japanese subjects must have been born in Japan, have both parents and all grandparents of Japanese origin, and not have lived outside of Japan for more than 5 years with no significant changes in lifestyle, including diet, since leaving Japan.
- Applicable to Non-Asian Subjects Only: Non-Asian subjects must have both parents and all grandparents of Non-Asian origin.
Who cannot join
- Have undergone any major surgical procedure within the 3 months prior to Screening.
- Test positive at Screening for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), or human immunodeficiency virus (HIV).
- Have a Screening systolic blood pressure (BP) reading of > 140 mmHg (> 150 mmHg in subjects > 45 years of age) OR a diastolic BP reading of > 90 mmHg after 5 minutes of supine rest.
- Have any of the following cardiac risk factors:
- Be taking any medication with a known effect of QT interval prolongation (see list of medications in Appendix 1)
- Have a cardiac pacemaker
Show all 18Show fewer
- Demonstrate on either the Screening ECG or the baseline ECG any evidence of atrial fibrillation, atrial flutter, complete right or left bundle branch block, or Wolff-Parkinson-White syndrome
- Demonstrate on the Screening ECG any morphology that renders measurement of QT interval imprecise (eg, neuromuscular artifact that cannot be readily eliminated, indistinct QRS onset, low-amplitude T wave, merged T and U waves, prominent U waves, arrhythmia)
- Have a history of a known risk factor for Torsade de Pointes, including any of the following:
- Personal or family history of congenital long QT syndrome, Brugada syndrome, or sudden death
- Unexplained syncope
- Heart failure
- Myocardial infarction
- Angina
- Certain clinically significant laboratory assessment findings, including hypokalemia, hypercalcemia, or hypomagnesemia
- Have had, including by voluntary donation, > 400 mL of blood collected within the 3 months prior to Screening.
- Have taken within the 14 days prior to study drug dosing any prescription medication, over-the counter medication, or nonprescription preparation-including vitamins, minerals, phytotherapeutic/herbal/plant-derived preparations, or grapefruit juice-unless deemed acceptable by the Investigator OR have taken within the 28 days prior to study drug dosing any restricted product known to strongly induce CYP3A4 metabolism (eg, St. John's Wort).
- Have participated in another clinical research study within the 3 months prior to Screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Coast Clinical Trial (WCCT) Global, Inc.
Cypress, California, 90630
About this study
Official title: A Phase 1, Single-Dose, Open-Label Study to Characterize and Compare the Pharmacokinetics, Safety, and Effect on QTc Interval of AG-348 in Healthy Subjects of Japanese Origin and Healthy Subjects of Non-Asian Origin
The purpose of this Phase I, single-dose, open-label trial is to evaluate the pharmacokinetics, safety, and effect on QTc interval of AG-348 in healthy, adult Japanese and Non-Asian subjects. The study plans to evaluate 3 cohorts of a single oral dose of AG-348 in Japanese and Non-Asian subjects. Pharmacokinetic sampling will take place serially at specified times during conduct of the study.
- Being tested
- AG-348
- Keywords
- Healthy, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG-348Drug
50 mg single-dose
AG-348Drug
5 mg single-dose
AG-348Drug
200 mg single-dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Not described Receives: Drug: AG-348 |
| Cohort B | Experimental | Not described Receives: Drug: AG-348 |
| Cohort C | Experimental | Not described Receives: Drug: AG-348 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
AG-348 Area Under the Curve
Measured: Pharmacokinetic sampling for AG-348 will be taken for 72 hours (4 days) after single dose
Cmax
AG-348 Maximum Plasma Concentration
Measured: Pharmacokinetic sampling for AG-348 will be taken for 72 hours (4 days) after single dose
Secondary outcomes (2)
Incidence of Adverse Events
Assessment of adverse events
Measured: 10 (± 1) days after single-dose of AG-348
QTc interval
QTc interval measurements
Measured: Change in QTc from baseline will be presented by race and by cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start9 Aug 2017
- Primary completion2 Oct 2017
- Study completion9 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Agios Pharmaceuticals, Inc.The sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agios Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Affairs Agios Pharmaceuticals, Inc, Study chair, Agios Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250598
- Sponsor's protocol ID
- AG348-C-004
- Status last verified
- Oct 2017
- First submitted
- 11 Aug 2017
- Last updated
- 19 Oct 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Dose, Open-Label Study to Characterize and Compare the Pharmacokinetics, Safety, and Effect on QTc Interval of AG-348 in Healthy Subjects of Japanese Origin and Healthy Subjects of Non-Asian Origin
- ClinicalTrials.gov ID
- NCT03250598
- Acronym / sponsor ID
- AG348-C-004
- Keywords
- Healthy, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Agios Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 2 Oct 2017 (actual)
- Study completion
- 9 Oct 2017 (actual)
- First posted
- 15 Aug 2017 (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.
The purpose of this Phase I, single-dose, open-label trial is to evaluate the pharmacokinetics, safety, and effect on QTc interval of AG-348 in healthy, adult Japanese and Non-Asian subjects. The study plans to evaluate 3 cohorts of a single oral dose of AG-348 in Japanese and Non-Asian subjects. Pharmacokinetic sampling will take place serially at specified times during conduct of the study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: AG-348 |
| Cohort B | Experimental | Drug: AG-348 |
| Cohort C | Experimental | Drug: AG-348 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be a male or female aged 18 to 55 years, inclusive.
- Have a body mass index (BMI) of ≥ 18.5 to ≤ 29.0 kg/m2 at Screening.
- Be healthy overall with no clinically significant medical abnormalities, as determined by the Investigator through evaluation of the subject's medical history and Screening vital signs, ECG, physical examination, and laboratory assessments.
- Applicable to Japanese Subjects Only: Japanese subjects must have been born in Japan, have both parents and all grandparents of Japanese origin, and not have lived outside of Japan for more than 5 years with no significant changes in lifestyle, including diet, since leaving Japan.
- Applicable to Non-Asian Subjects Only: Non-Asian subjects must have both parents and all grandparents of Non-Asian origin.
Key exclusion criteria (18 listed)
- Have undergone any major surgical procedure within the 3 months prior to Screening.
- Test positive at Screening for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), or human immunodeficiency virus (HIV).
- Have a Screening systolic blood pressure (BP) reading of > 140 mmHg (> 150 mmHg in subjects > 45 years of age) OR a diastolic BP reading of > 90 mmHg after 5 minutes of supine rest.
- Have any of the following cardiac risk factors:
- Have a history of a known risk factor for Torsade de Pointes, including any of the following:
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 |
|---|---|---|
| AG-34850 mg single-dose | Drug | Cohort A |
| AG-3485 mg single-dose | Drug | Cohort B |
| AG-348200 mg single-dose | Drug | Cohort C |
Primary outcome
AUC
Time frame: Pharmacokinetic sampling for AG-348 will be taken for 72 hours (4 days) after single dose
AG-348 Area Under the Curve
Cmax
Time frame: Pharmacokinetic sampling for AG-348 will be taken for 72 hours (4 days) after single dose
AG-348 Maximum Plasma Concentration
2 secondary outcomes
Incidence of Adverse Events
Time frame: 10 (± 1) days after single-dose of AG-348
QTc interval
Time frame: Change in QTc from baseline will be presented by race and by cohort
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 19 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Medical Affairs Agios Pharmaceuticals, Inc study chair
Agios Pharmaceuticals, Inc.
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 AG-348 in people with Healthy and Japanese, run by Agios Pharmaceuticals, 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 5 inclusion and 18 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 19 Oct 2017. 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. 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?
AUC (time frame: Pharmacokinetic sampling for AG-348 will be taken for 72 hours (4 days) after single dose). The study lists 2 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 19 Oct 2017.