Healthy ParticipantsPhase 1NCT04015687
A Study to Evaluate the Effect of AG-881 on the Pharmacokinetics of a Single Dose of Lamotrigine in Healthy Adults
A Phase 1 study testing AG-881 and Lamotrigine in people with Healthy Participants, run by Agios Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The main purpose of this study is to examine the effect of multiple doses of AG-881 on the pharmacokinetics (PK) of a single dose of lamotrigine in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AG-881 and Lamotrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 9 Oct 2019
- 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, adult, male or female participants, 18-55 years of age, inclusive, at screening;
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study, based on participant self-reporting;
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per square meter (kg/m^2) at screening;
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECG), as deemed by the principal investigator or designee;
- Liver function tests (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], and bilirubin [total and direct]) must be ≤ the upper limit of normal;
- Female participants must be of non-childbearing potential defined as a female who has undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
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- hysteroscopic sterilization;
- bilateral tubal ligation or bilateral salpingectomy;
- hysterectomy;
- bilateral oophorectomy;
- or is postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status;
- A non-vasectomized, male participant must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after the last dosing. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to the first dosing of study drug. A male who has been vasectomized less than 4 months prior to study first dosing must follow the same restrictions as a non-vasectomized male);
- If a male participant, must agree not to donate sperm from the first dosing until 90 days after the last dosing;
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
Who cannot join
- Participant is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study;
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the principal investigator or designee;
- History of any illness that, in the opinion of the principal investigator or designee, might confound the results of the study or pose an additional risk to the participant (e.g., history or presence of rashes) by their participation in the study;
- History or presence of ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, cardiomyopathy, family history of Long QT Syndrome), in the opinion of the principal investigator or designee;
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing;
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds;
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- Known medical history of progressive multifocal leukoencephalopathy;
- Presence of an active skin rash;
- Any positive responses on the Columbia-suicide severity rating scale (C-SSRS);
- Female participants of childbearing potential;
- Female participants with a positive pregnancy test or who are lactating;
- Positive urine drug or alcohol results at screening or first check-in;
- Positive results at screening for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies;
- Corrected QT interval by Fridericia (QTcF) is >450 milliseconds (msec), or Q wave, R wave, and S wave complex (QRS) interval >110 msec, or P wave to the start of the QRS complex (PR interval) >220 msec or participants who have ECG findings deemed abnormal with clinical significance by the principal investigator or designee at screening;
- Estimated creatinine clearance <90 millimeters per minute (mL/min) at screening;
- Unable to refrain from or anticipate the use of:
- Any drug, including prescription and non-prescription medications, herbal remedies, and vitamin supplements, beginning 14 days prior to the first dosing and throughout the study. After first dosing, ibuprofen (1.2 grams [g] per 24 hours) may be administered at the discretion of principal investigator or designee;
- Any drugs known to be strong inducers of cytochrome P450 (CYP) 3A enzymes or uridine 5´-diphospho-glucuronyl transferases (UGTs), including St. John's Wort, for 28 days prior to the first dosing and throughout the study. Appropriate sources (e.g., Flockhart Table™) will be consulted to confirm lack of pharmacokinetic/pharmacodynamic interaction with study drug;
- Refuses to abstain from grapefruit-containing foods or beverages or Seville orange containing foods or beverages from 14 days prior to the first dosing and throughout the study;
- Has been on a diet incompatible with the on-study diet, in the opinion of the principal investigator or designee, within the 30 days prior to the first dosing and throughout the study;
- Donation of blood or significant blood loss within 56 days prior to the first dose;
- Plasma donation within 7 days prior to the first dose;
- Participation in another clinical study within 30 days prior to the first dose. The 30-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study to Evaluate the Effect of AG-881 on the Pharmacokinetics of a Single Dose of Lamotrigine in Healthy Adult Subjects
The main purpose of this study is to examine the effect of multiple doses of AG-881 on the pharmacokinetics (PK) of a single dose of lamotrigine in healthy adults.
- Conditions
- Healthy Participants
- Being tested
- AG-881, Lamotrigine
- Keywords
- Pharmacokinetic study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG-881Drug
Supplied as uncoated tablets.
LamotrigineDrug
Also called LAMICTAL®
Supplied as tablets of LAMICTAL® or generic equivalent.
| Study group | Role | What they receive |
|---|---|---|
| AG-881 (Group 1) | Experimental | On Day 1 of Period 1, Group 1 participants will receive a single 50-milligram (mg) oral dose of lamotrigine at Hour 0. In Period 2, they will receive 50-mg oral doses of AG-881 once daily (QD) for 15 consecutive days (Days 1 to 15), with a single 50-mg oral dose of lamotrigine coadministered at Hour 0 on Day 14. Receives: Drug: AG-881; Drug: Lamotrigine |
| AG-881 (Group 2) | Experimental | Following a safety and tolerability review of the data from at least 7 days of AG-881 dosing of Group 1 participants in Period 2, Group 2 participants will receive a single 50-mg oral dose of lamotrigine at Hour 0 in Period 1, and 50-mg oral doses of AG-881 QD for 15 consecutive days (Days 1 to 15), with a single 50-mg oral dose of lamotrigine coadministered at Hour 0 on Day 14 in Period 2. Receives: Drug: AG-881; Drug: Lamotrigine |
| AG-881 (Group 3) | Experimental | Following a safety and tolerability review of the data from Group 1 participants, and from at least 7 days of AG-881 dosing of Group 2 participants in Period 2, Group 3 participants will receive a single 50-mg oral dose of lamotrigine at Hour 0 in Period 1; and 50-mg oral doses of AG-881 QD for 15 consecutive days (Days 1 to 15) with a single 50-mg oral dose of lamotrigine coadministered at Hour 0 on Day 14 in Period 2. Receives: Drug: AG-881; Drug: Lamotrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) for Lamotrigine Administered with Interacting Drug AG-881
Measured: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Area under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) for Lamotrigine Administered without Interacting Drug AG-881
Measured: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Maximum Observed Plasma Concentration (Cmax) for Lamotrigine Administered with Interacting Drug AG-881
Measured: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Maximum Observed Plasma Concentration (Cmax) for Lamotrigine Administered without Interacting Drug AG-881
Measured: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Area under the Concentration-time Curve, from Time 0 to the Last Observed Non-zero Concentration (t) (AUC0-t) for Lamotrigine Administered with Interacting Drug AG-881
Measured: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Area under the Concentration-time Curve, from Time 0 to the Last Observed Non-zero Concentration (t) (AUC0-t) for Lamotrigine Administered without Interacting Drug AG-881
Measured: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Percent of AUC0-inf Extrapolated (AUC%extrap) for Lamotrigine Administered with Interacting Drug AG-881
Measured: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Percent of AUC0-inf Extrapolated (AUC%extrap) for Lamotrigine Administered without Interacting Drug AG-881
Measured: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Time to Maximum Observed Plasma Concentration (Tmax) for Lamotrigine Administered with Interacting Drug AG-881
Measured: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Time to Maximum Observed Plasma Concentration (Tmax) for Lamotrigine Administered without Interacting Drug AG-881
Measured: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Apparent Terminal Elimination Rate Constant (Kel) for Lamotrigine Administered with Interacting Drug AG-881
Measured: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Apparent Terminal Elimination Rate Constant (Kel) for Lamotrigine Administered without Interacting Drug AG-881
Measured: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Apparent Terminal Elimination Half-life (t½) for Lamotrigine Administered with Interacting Drug AG-881
Measured: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Apparent Terminal Elimination Half-life (t½) for Lamotrigine Administered without Interacting Drug AG-881
Measured: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Apparent Total Plasma Clearance after Oral (Extravascular) Administration (CL/F) for Lamotrigine Administered with Interacting Drug AG-881
Measured: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Apparent Total Plasma Clearance after Oral (Extravascular) Administration (CL/F) for Lamotrigine Administered without Interacting Drug AG-881
Measured: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Apparent Volume of Distribution during the Terminal Elimination Phase after Oral (Extravascular) Administration (Vz/F) for Lamotrigine Administered with Interacting Drug AG-881
Measured: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Apparent Volume of Distribution during the Terminal Elimination Phase after Oral (Extravascular) Administration (Vz/F) for Lamotrigine Administered without Interacting Drug AG-881
Measured: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Secondary outcomes (6)
Percentage of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence associated with the use of a drug, whether or not considered drug-related.
Measured: Up to approximately 4 weeks
Columbia-suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a questionnaire scale to detect emergent suicide symptoms (suicidal ideation or actual suicidal behavior). Questions are either answered yes/no or are on a scale of 1 (low severity) to 5 (high severity).
Measured: Up to approximately 4 weeks
Percentage of Participants with Abnormalities in 12-lead Electrocardiograms (ECGs)
Measured: Up to approximately 4 weeks
Percentage of Participants with Abnormalities in Vital Sign Measurements
Vital signs will include body temperature, respiratory rate, blood pressure, and heart rate.
Measured: Up to approximately 4 weeks
Percentage of Participants with Abnormalities in Clinical Laboratory Tests
Clinical laboratory assessments will include hematology, serum chemistry, coagulation, and urinalysis.
Measured: Up to approximately 4 weeks
Percentage of Participants with Abnormalities in Physical Examinations
Measured: Up to approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start15 Jul 2019
- Primary completion9 Oct 2019
- Study completion9 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agios Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Affairs, Study director, Agios Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015687
- Sponsor's protocol ID
- AG881-C-006
- Status last verified
- Oct 2019
- First submitted
- 3 Jul 2019
- Last updated
- 14 Oct 2019
- 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 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate the Effect of AG-881 on the Pharmacokinetics of a Single Dose of Lamotrigine in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04015687
- Acronym / sponsor ID
- AG881-C-006
- Conditions
- Healthy Participants
- Keywords
- Pharmacokinetic study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Agios Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 9 Oct 2019 (actual)
- First posted
- 11 Jul 2019 (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 main purpose of this study is to examine the effect of multiple doses of AG-881 on the pharmacokinetics (PK) of a single dose of lamotrigine in healthy adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AG-881 (Group 1) | Experimental | Drug: AG-881, Drug: LamotrigineOn Day 1 of Period 1, Group 1 participants will receive a single 50-milligram (mg) oral dose of lamotrigine at Hour 0. In Period 2, they will receive 50-mg oral doses of AG-881 once daily (QD) for 15 consecutive days (Days 1 to 15), with a single 50-mg oral dose of lamotrigine coadministered at Hour 0 on Day 14. |
| AG-881 (Group 2) | Experimental | Drug: AG-881, Drug: LamotrigineFollowing a safety and tolerability review of the data from at least 7 days of AG-881 dosing of Group 1 participants in Period 2, Group 2 participants will receive a single 50-mg oral dose of lamotrigine at Hour 0 in Period 1, and 50-mg oral doses of AG-881 QD for 15 consecutive days (Days 1 to 15), with a single 50-mg oral dose of lamotrigine coadministered at Hour 0 on Day 14 in Period 2. |
| AG-881 (Group 3) | Experimental | Drug: AG-881, Drug: LamotrigineFollowing a safety and tolerability review of the data from Group 1 participants, and from at least 7 days of AG-881 dosing of Group 2 participants in Period 2, Group 3 participants will receive a single 50-mg oral dose of lamotrigine at Hour 0 in Period 1; and 50-mg oral doses of AG-881 QD for 15 consecutive days (Days 1 to 15) with a single 50-mg oral dose of lamotrigine coadministered at Hour 0 on Day 14 in Period 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy, adult, male or female participants, 18-55 years of age, inclusive, at screening;
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study, based on participant self-reporting;
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per square meter (kg/m^2) at screening;
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECG), as deemed by the principal investigator or designee;
- Liver function tests (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], and bilirubin [total and direct]) must be ≤ the upper limit of normal;
Key exclusion criteria (23 listed)
- Participant is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study;
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the principal investigator or designee;
- History of any illness that, in the opinion of the principal investigator or designee, might confound the results of the study or pose an additional risk to the participant (e.g., history or presence of rashes) by their participation in the study;
- History or presence of ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, cardiomyopathy, family history of Long QT Syndrome), in the opinion of the principal investigator or designee;
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing;
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-881Supplied as uncoated tablets. | Drug | AG-881 (Group 1), AG-881 (Group 2), AG-881 (Group 3) |
| LamotrigineAlso: LAMICTAL®Supplied as tablets of LAMICTAL® or generic equivalent. | Drug | AG-881 (Group 1), AG-881 (Group 2), AG-881 (Group 3) |
Primary outcome
Area under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) for Lamotrigine Administered with Interacting Drug AG-881
Time frame: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Area under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) for Lamotrigine Administered without Interacting Drug AG-881
Time frame: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Maximum Observed Plasma Concentration (Cmax) for Lamotrigine Administered with Interacting Drug AG-881
Time frame: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Maximum Observed Plasma Concentration (Cmax) for Lamotrigine Administered without Interacting Drug AG-881
Time frame: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Area under the Concentration-time Curve, from Time 0 to the Last Observed Non-zero Concentration (t) (AUC0-t) for Lamotrigine Administered with Interacting Drug AG-881
Time frame: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Area under the Concentration-time Curve, from Time 0 to the Last Observed Non-zero Concentration (t) (AUC0-t) for Lamotrigine Administered without Interacting Drug AG-881
Time frame: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Percent of AUC0-inf Extrapolated (AUC%extrap) for Lamotrigine Administered with Interacting Drug AG-881
Time frame: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Percent of AUC0-inf Extrapolated (AUC%extrap) for Lamotrigine Administered without Interacting Drug AG-881
Time frame: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Time to Maximum Observed Plasma Concentration (Tmax) for Lamotrigine Administered with Interacting Drug AG-881
Time frame: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Time to Maximum Observed Plasma Concentration (Tmax) for Lamotrigine Administered without Interacting Drug AG-881
Time frame: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Apparent Terminal Elimination Rate Constant (Kel) for Lamotrigine Administered with Interacting Drug AG-881
Time frame: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Apparent Terminal Elimination Rate Constant (Kel) for Lamotrigine Administered without Interacting Drug AG-881
Time frame: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Apparent Terminal Elimination Half-life (t½) for Lamotrigine Administered with Interacting Drug AG-881
Time frame: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Apparent Terminal Elimination Half-life (t½) for Lamotrigine Administered without Interacting Drug AG-881
Time frame: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Apparent Total Plasma Clearance after Oral (Extravascular) Administration (CL/F) for Lamotrigine Administered with Interacting Drug AG-881
Time frame: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Apparent Total Plasma Clearance after Oral (Extravascular) Administration (CL/F) for Lamotrigine Administered without Interacting Drug AG-881
Time frame: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Apparent Volume of Distribution during the Terminal Elimination Phase after Oral (Extravascular) Administration (Vz/F) for Lamotrigine Administered with Interacting Drug AG-881
Time frame: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Apparent Volume of Distribution during the Terminal Elimination Phase after Oral (Extravascular) Administration (Vz/F) for Lamotrigine Administered without Interacting Drug AG-881
Time frame: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
6 secondary outcomes
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to approximately 4 weeks
Columbia-suicide Severity Rating Scale (C-SSRS)
Time frame: Up to approximately 4 weeks
Percentage of Participants with Abnormalities in 12-lead Electrocardiograms (ECGs)
Time frame: Up to approximately 4 weeks
Percentage of Participants with Abnormalities in Vital Sign Measurements
Time frame: Up to approximately 4 weeks
Percentage of Participants with Abnormalities in Clinical Laboratory Tests
Time frame: Up to approximately 4 weeks
Percentage of Participants with Abnormalities in Physical Examinations
Time frame: Up to approximately 4 weeks
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 14 Oct 2019.
- 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 study director
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-881 and Lamotrigine in people with Healthy Participants, 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 14 inclusion and 23 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 14 Oct 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. 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?
Area under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) for Lamotrigine Administered with Interacting Drug AG-881 (time frame: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)). The study lists 18 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 14 Oct 2019.