HealthyPhase 1NCT03071770
Japanese Bridging Study of Ivosidenib (AG-120) in Healthy Subjects
A Phase 1 study testing ivosidenib (AG-120) in people with Healthy, 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 and safety of ivosidenib (AG-120) in healthy, adult male Japanese and Caucasian subjects. The study plans to evaluate 3 cohorts of a single oral dose of ivosidenib (AG-120) in Japanese and Caucasian subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ivosidenib (AG-120)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2017to 6 Sep 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Applicable to Japanese Subjects Only: Japanese subjects must have been born in Japan, have both parents and grandparents of Japanese origin, and not have lived outside of Japan for more than 5 years.
- Applicable to Caucasian Subjects Only: Non-Japanese subjects must be Caucasian (ie, White) but may be of any ethnicity.
- Healthy male subjects between 18 and 55 years of age (inclusive).
- Provision of voluntary, written informed consent.
- Capable of adhering to trial restrictions and examination schedules, in the opinion of the Investigator.
- Must be able to communicate with the Investigator.
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- Must be in good health as determined by the Investigator according to past medical history, physical examination, vital signs, clinical laboratory test results, and ECGs.
- Must have a body mass index (BMI) between 18 and 29 kg/m2 (inclusive), and body weight between 50-120kg.
- Clinical laboratory test results (serum chemistry, hematology, and urinalysis) must be within normal limits or considered by the Investigator to be not clinically significant after confirmation with the Agios Medical Monitor.
- Vital signs (systolic and diastolic blood pressure, pulse rate, and oral body temperature) will be assessed in the supine position after the subject has rested for at least 5 minutes. Subject must be afebrile with vital signs within the following ranges at screening, Day -1 and pre dose: Systolic blood pressure: 90 to 140 mmHg; Diastolic blood pressure: 50 to 90 mmHg; Pulse rate: 40 to 110 bpm
- Must have a normal or clinically acceptable 12-lead ECG no later than Day -1. Subjects must have a pre-dose QT interval corrected for heart rate using Fridericia's formula (QTcF) value or average of 3 values, ≤450 msec. An ECG may be repeated once to determine subject eligibility after confirmation with the Agios Medical Monitor.
- Subjects (with or without vasectomy) must agree to abstain from sexual intercourse or agree to the use of highly effective contraceptive methods (at screening and throughout the course of the trial) and should avoid fathering a child during the course of the trial and for 90 days following the dose of the IMP. Subjects must refrain from sperm donations for the entire duration of the trial and for 90 days following the dose of AG 120.
Who cannot join
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from providing informed consent or participating in the trial in the opinion of the Investigator.
- Any condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he were to participate in the trial.
- Recent history (within 3 years prior to dosing) of any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorder.
- Use of any prescribed systemic or topical medication within 30 days or 5 terminal half-lives, whichever is longer, of IMP administration.
- Exposure to an investigational drug within 30 days prior to IMP administration or 5 half lives of that investigational drug, if known (whichever is longer).
- Use of any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines, eg, St. John's Wort) within 7 days of IMP administration.
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- Any surgical or medical condition that could affect drug absorption, distribution, metabolism, or excretion (eg, gastrectomy and cholecystectomy)
- Subjects who plan to have any elective or medical procedures during the conduct of the trial (eg, dental procedure).
- History of clinically significant multiple drug allergies (ie, 2 or more).
- Any clinically significant allergic disease.
- History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) within 2 years prior to IMP administration, or positive drug screen test due to illicit drugs at any time prior to IMP administration during the screening period.
- History of alcohol abuse within 2 years prior to IMP administration, or positive alcohol screen at any time prior to IMP administration during the screening period.
- History of smoking within 3 months prior to IMP administration, or positive urine cotinine screen at any time prior to IMP administration during the screening period.
- Known to have human immunodeficiency virus (HIV), hepatitis, or known to be a carrier of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV Ab), or have positive results at screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Coast Clinical Trial (WCCT)
Cypress, California, 90630
About this study
Official title: A Phase 1, Single-Dose, Open-Label Trial to Evaluate the Pharmacokinetics and Safety of AG-120 in Healthy Male Japanese Subjects Relative to Healthy Male Caucasian Subjects
The purpose of this Phase I, single-dose, open-label trial is to evaluate the pharmacokinetics and safety of ivosidenib (AG-120) in healthy, adult male Japanese and Caucasian subjects. The study plans to evaluate 3 cohorts of a single oral dose of ivosidenib (AG-120) in Japanese and Caucasian subjects. Pharmacokinetic sampling will take place serially through-out the duration of subject participation.
- Conditions
- Healthy
- Being tested
- ivosidenib (AG-120)
- Keywords
- Healthy Volunteers, Japanese, Caucasian
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivosidenib (AG-120)Drug
A single-dose of ivosidenib (AG-120) administered in healthy Japanese and Caucasian subjects
| Study group | Role | What they receive |
|---|---|---|
| ivosidenib (AG-120) | Experimental | Not described Receives: Drug: ivosidenib (AG-120) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
AG-120 Area Under the Curve
Measured: Pharmacokinetic sampling for ivosidenib (AG-120) will be taken for 504 hours (21 days) after single dose
Cmax
AG-120 Maximum Plasma Concentration
Measured: Pharmacokinetic sampling for ivosidenib (AG-120) will be taken for 504 hours (21 days) after single dose
Secondary outcomes (1)
Incidence of Adverse Events
Assessment of adverse events
Measured: 28 days after single-dose ivosidenib (AG-120)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start31 Mar 2017
- Primary completion9 May 2017
- Study completion6 Sep 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- NCT03071770
- Sponsor's protocol ID
- AG120-C-006
- Status last verified
- Jan 2018
- First submitted
- 2 Mar 2017
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- 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 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Dose, Open-Label Trial to Evaluate the Pharmacokinetics and Safety of AG-120 in Healthy Male Japanese Subjects Relative to Healthy Male Caucasian Subjects
- ClinicalTrials.gov ID
- NCT03071770
- Acronym / sponsor ID
- AG120-C-006
- Conditions
- Healthy
- Keywords
- Healthy Volunteers, Japanese, Caucasian
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Agios Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 9 May 2017 (actual)
- Study completion
- 6 Sep 2017 (actual)
- First posted
- 7 Mar 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 and safety of ivosidenib (AG-120) in healthy, adult male Japanese and Caucasian subjects. The study plans to evaluate 3 cohorts of a single oral dose of ivosidenib (AG-120) in Japanese and Caucasian subjects. Pharmacokinetic sampling will take place serially through-out the duration of subject participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ivosidenib (AG-120) | Experimental | Drug: ivosidenib (AG-120) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Applicable to Japanese Subjects Only: Japanese subjects must have been born in Japan, have both parents and grandparents of Japanese origin, and not have lived outside of Japan for more than 5 years.
- Applicable to Caucasian Subjects Only: Non-Japanese subjects must be Caucasian (ie, White) but may be of any ethnicity.
- Healthy male subjects between 18 and 55 years of age (inclusive).
- Provision of voluntary, written informed consent.
- Capable of adhering to trial restrictions and examination schedules, in the opinion of the Investigator.
Key exclusion criteria (14 listed)
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from providing informed consent or participating in the trial in the opinion of the Investigator.
- Any condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he were to participate in the trial.
- Recent history (within 3 years prior to dosing) of any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorder.
- Use of any prescribed systemic or topical medication within 30 days or 5 terminal half-lives, whichever is longer, of IMP administration.
- Exposure to an investigational drug within 30 days prior to IMP administration or 5 half lives of that investigational drug, if known (whichever is longer).
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 |
|---|---|---|
| ivosidenib (AG-120)A single-dose of ivosidenib (AG-120) administered in healthy Japanese and Caucasian subjects | Drug | ivosidenib (AG-120) |
Primary outcome
AUC
Time frame: Pharmacokinetic sampling for ivosidenib (AG-120) will be taken for 504 hours (21 days) after single dose
AG-120 Area Under the Curve
Cmax
Time frame: Pharmacokinetic sampling for ivosidenib (AG-120) will be taken for 504 hours (21 days) after single dose
AG-120 Maximum Plasma Concentration
1 secondary outcome
Incidence of Adverse Events
Time frame: 28 days after single-dose ivosidenib (AG-120)
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 11 Jan 2018.
- 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 ivosidenib (AG-120) in people with Healthy, 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 12 inclusion and 14 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 11 Jan 2018. 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 ivosidenib (AG-120) will be taken for 504 hours (21 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 11 Jan 2018.