Healthy VolunteersPhase 1NCT03991312
Study to Evaluate the Effect of Multiple Doses of Itraconazole and Rifampin on the Single-Dose Pharmacokinetics of Mitapivat Sulfate (AG-348) in Healthy Adult Participants
A Phase 1 study testing itraconazole, rifampin and mitapivat sulfate in people with Healthy Volunteers, run by Agios Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
Part 1 of this study will determine the effect of multiple-dose itraconazole, a strong cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp) inhibitor, on the single-dose pharmacokinetic(s) (PK) of mitapivat sulfate in healthy adult participants. 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?
- itraconazole, rifampin and mitapivat sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2019to 10 Sep 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 (non-childbearing potential), 18-55 years of age, inclusive, at the time of providing written informed consent;
- Continuous non-smoker who has not used nicotine-containing products for at least 12 months prior to screening, based on participant self-reporting, and agrees to abstain from use throughout the study;
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m2) at screening;
- Medically healthy, with no clinically significant conditions or abnormalities, as determined by the principal investigator (PI) or designee, through evaluation of medical history and screening vital signs, 12-lead electrocardiogram (ECG) results, physical examination findings, and clinical laboratory test results;
- A female participant must be of non-childbearing potential and must have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
- hysteroscopic sterilization;
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- bilateral tubal ligation or bilateral salpingectomy;
- hysterectomy;
- bilateral oophorectomy.
- or be postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels at screening consistent with postmenopausal status;
- A male participant (with or without prior vasectomy) must agree to use a condom with spermicide or abstain from sexual intercourse from the time of providing written informed consent until 90 days after the last dose of study drug;
- If male, must agree not to donate sperm from the first dosing until 90 days after the last dose of study drug;
- Understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the study procedures and the protocol requirements, and has provided signed written informed consent prior to performing any study procedures, including screening procedures;
Who cannot join
- 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 any clinically significant medical or psychiatric condition or disease or clinically significant laboratory abnormality that, in the opinion of the PI or designee, might confound the results of the study, compromise the ability of the participant to complete study procedures, and/or pose an additional risk to the participant by their participation in the study. This includes seizure disorders, transient ischemic attacks, or easy bruising;
- History or presence of a medical condition or surgical procedure that, in the opinion of the PI or designee, may potentially interfere with absorption, distribution, metabolism, or excretion of the study drugs;
- History or presence of alcohol or drug abuse within the past 2 years prior to screening;
- History or presence of hypersensitivity, idiosyncratic reaction, or serious adverse reaction to any of the study drugs or to their formulation excipients;
- Female participants of childbearing potential;
Show all 36Show fewer
- Female participants with a positive serum pregnancy test at screening or check-in or who are breastfeeding;
- Positive urine drug or alcohol results at screening or check-in;
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody;
- Supine blood pressure is less than 90/40 milliliters of mercury (mmHg) or greater than 140/90 mmHg at screening. If the participant's systolic blood pressure reading exceeds 140 mmHg or the diastolic blood pressure reading exceeds 90 mmHg due to what may be, in the opinion of the PI or designee, an episode of transient anxiety, the reading may be repeated, and the resulting blood pressure measurement used to determine eligibility;
- Supine heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening. If the participant's heart rate exceeds 99 bpm due to what may be, in the opinion of the PI or designee, an episode of transient anxiety, the reading may be repeated, and the resulting heart rate measurement used to determine eligibility;
- QTcF interval is >450 milliseconds (msec) (males) or >470 msec (females) or has ECG findings deemed abnormal with clinical significance by the PI or designee at screening;
- Estimated creatinine clearance < 90 mL/min at screening (Cockcroft-Gault formula);
- Unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, proton pump inhibitors, H2-antagonists, herbal remedies, and vitamin supplements, beginning 28 days prior to the first dosing and throughout the study. Additionally, any drugs (with the exception of the study drugs) known to be clinically significant inhibitors or inducers of CYP3A, CYP2C9, CYP2C8, CYP2C19, and CYP1A2 enzymes and/or P-gp, including St. John's Wort, beginning 28 days prior to the first dosing and throughout the study. Appropriate sources (e.g., Flockhart TableTM) will be consulted to confirm lack of PK/PD interaction with study drugs. After first dosing, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the PI or designee;
- Has consumed foods or beverages containing caffeine or xanthines 24 hours prior to the first dosing and is not willing to refrain from consumption of these foods or beverages throughout the study;
- Has consumed alcohol 48 hours prior to the first dosing and is not willing to refrain from consumption of alcohol throughout the study;
- Has consumed foods or beverages containing grapefruit or Seville oranges for 14 days prior to the first dosing and is not willing to refrain from consumption of these foods or beverages throughout the study;
- Has consumed fruit juices 72 hours prior to the first dosing and is not willing to refrain from consumption of these juices throughout the study
- Has consumed vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussel sprouts, and mustard), and charbroiled meats for 7 days prior to first dosing and is not willing to refrain from consumption of these foods throughout the study;
- Has been on a diet incompatible with the on-study diet, in the opinion of the PI or designee, within the 30 days prior to the first dosing;
- Donation of blood or significant blood loss (≥500 mL) within 3 months prior to the first dosing and must be willing to refrain from voluntary blood donation for at least 30 days after the last dose of study drug;
- Plasma donation within 7 days prior to screening;
- Has liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin that are greater than the upper limit of normal at screening or check-in (confirmation of results may be done once);
- Has platelet, hemoglobin, and hematocrit that are below the lower limit of normal at screening or check-in (confirmation of results may be done once).
- History or presence of liver disease;
- Are currently enrolled in or have participated in another clinical study involving ongoing therapy with any investigational or marketed product or placebo within 3 months prior to the first dosing. The 3-month 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 Treatment Period 1 of the current study;
- Has exposure to any investigational drug within 5 times the elimination half-life, if known (for marketed product) or within 3 months (if the elimination half-life is unknown) prior to first dosing;
- Has undergone any major surgical procedure within 3 months prior to Screening;
- History or presence of a primary malignancy, with the exception of a malignancy that has been curatively treated and for which the participant has displayed no evidence of disease within the 12 months prior to Screening;
- History or presence of a clinically significant allergy requiring medical treatment, as assessed by the PI or designee;
- Has glucose-6-phosphate dehydrogenase deficiency;
- Has veins that are unsuitable for multiple venipunctures/cannulation, as assessed by the PI or designee at screening;
- For Part 1 Only (Itraconazole):
- History or presence of any of the following, deemed clinically significant by the PI or designee:
- History or presence of ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, myocardial infarction, angina, unexplained syncope, personal or family history of Long QT Syndrome, Brugada syndrome, or sudden death).;
- Uncorrected hypokalemia (potassium levels < 3.7) and/or hypomagnesemia (magnesium levels < 1.9).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Part, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Multiple Doses of Itraconazole and Rifampin on the Single-Dose Pharmacokinetics of Mitapivat Sulfate (AG-348) in Healthy Adult Subjects
Part 1 of this study will determine the effect of multiple-dose itraconazole, a strong cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp) inhibitor, on the single-dose pharmacokinetic(s) (PK) of mitapivat sulfate in healthy adult participants. Part 2 of this study will determine the effect of multiple-dose rifampin, a strong CYP3A4 and P-gp inducer, on the single-dose pharmacokinetic(s) (PK) of mitapivat sulfate in healthy adult participants.
Read the detailed description
This study consists of 2 periods and 2 parts. Participants will be placed in Part 1 or Part 2, and cannot participate in both:
Part 1, Period 1 includes a screening period up to 28 days prior to dosing and treatment on Day 1.
Part 1, Period 2 includes a treatment period from Day 1 to Day 9 and a possible follow-up, up to 28 days after the last dose of study drug.
Part 2, Period 1 includes a screening period up to 28 days prior to dosing and treatment on Day 1.
Part 2, Period 2 includes a treatment period from Day 1 to Day 12 and a possible follow-up, up to 28 days after the last dose of study drug.
- Conditions
- Healthy Volunteers
- Being tested
- itraconazole, rifampin, mitapivat sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
itraconazoleDrug
Participants will receive an oral solution as described in the arm description.
rifampinDrug
Participants will receive oral capsule(s) as described in the arm description.
mitapivat sulfateDrug
Also called AG348
Participants will receive an oral tablet as described in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Period 1: Day 1, participants will receive 20 milligrams (mg) of mitapivat sulfate.
Period 2: Day 1 to Day 9, participants will receive 200 mg of itraconazole, once daily and 20 mg of mitapivat sulfate on Day 5. Receives: Drug: itraconazole; Drug: mitapivat sulfate |
| Part 2 | Experimental | Period 1: Day 1, participants will receive 50 milligrams (mg) of mitapivat sulfate.
Period 2: Day 1 to Day 12, participants will receive 600 mg of rifampin, once daily and 50 mg of mitapivat sulfate on Day 8. Receives: Drug: rifampin; Drug: mitapivat sulfate |
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 the Last Measurable Concentration (AUC0-t) of Mitapivat Sulfate with and without Itraconazole
Measured: Predose and at various timepoints through 120 hours postdose
Area Under the Concentration-Time Curve, from Time 0 to the Last Measurable Concentration (AUC0-t) of Mitapivat Sulfate with and without Rifampin
Measured: Predose and at various timepoints through 120 hours postdose
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Mitapivat Sulfate with and without Itraconazole
Measured: Predose and at various timepoints through 120 hours postdose
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Mitapivat Sulfate with and without Rifampin
Measured: Predose and at various timepoints through 120 hours postdose
Maximum Observed Plasma Concentration (Cmax) of Mitapivat Sulfate with and without Itraconazole
Measured: Predose and at various timepoints through 120 hours postdose
Maximum Observed Plasma Concentration (Cmax) of Mitapivat Sulfate with and without Rifampin
Measured: Predose and at various timepoints through 120 hours postdose
Secondary outcomes (21)
Area Under the Concentration-Time Curve, from Time 0 to Hour 24 (AUC0-24) of Mitapivat Sulfate and AGI-8702 with and without Itraconazole
Measured: Predose and at various timepoints through 120 hours postdose
Area Under the Concentration-Time Curve, from Time 0 to Hour 24 (AUC0-24) of Mitapivat Sulfate and AGI-8702 with and without Rifampin
Measured: Predose and at various timepoints through 120 hours postdose
Percent of AUC0-inf Extrapolated (AUC%extrap) of Mitapivat Sulfate and AGI-8702 with and without Itraconazole
Measured: Predose and at various timepoints through 120 hours postdose
Percent of AUC0-inf Extrapolated (AUC%extrap) of Mitapivat Sulfate and AGI-8702 with and without Rifampin
Measured: Predose and at various timepoints through 120 hours postdose
Time of the Last Measurable Concentration (Tlast) of Mitapivat Sulfate and AGI-8702 with and without Itraconazole
Measured: Predose and at various timepoints through 120 hours postdose
Time of the Last Measurable Concentration (Tlast) of Mitapivat Sulfate and AGI-8702 with and without Rifampin
Measured: Predose and at various timepoints through 120 hours postdose
Time to Reach Cmax (Tmax) of Mitapivat Sulfate and AGI-8702 with and without Itraconazole
Measured: Predose and at various timepoints through 120 hours postdose
Time to Reach Cmax (Tmax) of Mitapivat Sulfate and AGI-8702 with and without Rifampin
Measured: Predose and at various timepoints through 120 hours postdose
Apparent First-Order Terminal Elimination Half-Life (t1/2) of Mitapivat Sulfate and AGI-8702 with and without Itraconazole
Measured: Predose and at various timepoints through 120 hours postdose
Apparent First-Order Terminal Elimination Half-Life (t1/2) of Mitapivat Sulfate and AGI-8702 with and without Rifampin
Measured: Predose and at various timepoints through 120 hours postdose
Apparent Volume of Distribution During the Terminal Elimination Phase After Oral (Extravascular) Administration (Vz/F) of Mitapivat Sulfate with and without Itraconazole
Measured: Predose and at various timepoints through 120 hours postdose
Apparent Volume of Distribution During the Terminal Elimination Phase After Oral (Extravascular) Administration (Vz/F) of Mitapivat Sulfate with and without Rifampin
Measured: Predose and at various timepoints through 120 hours postdose
Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Mitapivat Sulfate with and without Itraconazole
Measured: Predose and at various timepoints through 120 hours postdose
Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Mitapivat Sulfate with and without Rifampin
Measured: Predose and at various timepoints through 120 hours postdose
AUC0-t of AGI-8702 with and without Itraconazole
Measured: Predose and at various timepoints through 120 hours postdose
AUC0-t of AGI-8702 with and without Rifampin
Measured: Predose and at various timepoints through 120 hours postdose
AUC0-inf of AGI-8702 with and without Itraconazole
Measured: Predose and at various timepoints through 120 hours postdose
AUC0-inf of AGI-8702 with and without Rifampin
Measured: Predose and at various timepoints through 120 hours postdose
Cmax of AGI-8702 with and without Itraconazole
Measured: Predose and at various timepoints through 120 hours postdose
Cmax of AGI-8702 with and without Rifampin
Measured: Predose and at various timepoints through 120 hours postdose
Percentage of Participants Experiencing an Adverse Event
Measured: Baseline up to a maximum of 38 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start20 Jun 2019
- Primary completion14 Aug 2019
- Study completion10 Sep 2019
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agios Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Affairs, Study chair, Agios Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991312
- Sponsor's protocol ID
- AG348-C-012
- Status last verified
- Oct 2019
- First submitted
- 17 Jun 2019
- Last updated
- 23 Oct 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Multiple Doses of Itraconazole and Rifampin on the Single-Dose Pharmacokinetics of Mitapivat Sulfate (AG-348) in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03991312
- Acronym / sponsor ID
- AG348-C-012
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Agios Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 14 Aug 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 19 Jun 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.
Part 1 of this study will determine the effect of multiple-dose itraconazole, a strong cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp) inhibitor, on the single-dose pharmacokinetic(s) (PK) of mitapivat sulfate in healthy adult participants. Part 2 of this study will determine the effect of multiple-dose rifampin, a strong CYP3A4 and P-gp inducer, on the single-dose pharmacokinetic(s) (PK) of mitapivat sulfate in healthy adult participants.
Detailed description
This study consists of 2 periods and 2 parts. Participants will be placed in Part 1 or Part 2, and cannot participate in both:
Part 1, Period 1 includes a screening period up to 28 days prior to dosing and treatment on Day 1.
Part 1, Period 2 includes a treatment period from Day 1 to Day 9 and a possible follow-up, up to 28 days after the last dose of study drug.
Part 2, Period 1 includes a screening period up to 28 days prior to dosing and treatment on Day 1.
Part 2, Period 2 includes a treatment period from Day 1 to Day 12 and a possible follow-up, up to 28 days after the last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: itraconazole, Drug: mitapivat sulfatePeriod 1: Day 1, participants will receive 20 milligrams (mg) of mitapivat sulfate. Period 2: Day 1 to Day 9, participants will receive 200 mg of itraconazole, once daily and 20 mg of mitapivat sulfate on Day 5. |
| Part 2 | Experimental | Drug: rifampin, Drug: mitapivat sulfatePeriod 1: Day 1, participants will receive 50 milligrams (mg) of mitapivat sulfate. Period 2: Day 1 to Day 12, participants will receive 600 mg of rifampin, once daily and 50 mg of mitapivat sulfate on Day 8. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy, adult, male or female (non-childbearing potential), 18-55 years of age, inclusive, at the time of providing written informed consent;
- Continuous non-smoker who has not used nicotine-containing products for at least 12 months prior to screening, based on participant self-reporting, and agrees to abstain from use throughout the study;
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m2) at screening;
- Medically healthy, with no clinically significant conditions or abnormalities, as determined by the principal investigator (PI) or designee, through evaluation of medical history and screening vital signs, 12-lead electrocardiogram (ECG) results, physical examination findings, and clinical laboratory test results;
- A female participant must be of non-childbearing potential and must have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
Key exclusion criteria (36 listed)
- 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 any clinically significant medical or psychiatric condition or disease or clinically significant laboratory abnormality that, in the opinion of the PI or designee, might confound the results of the study, compromise the ability of the participant to complete study procedures, and/or pose an additional risk to the participant by their participation in the study. This includes seizure disorders, transient ischemic attacks, or easy bruising;
- History or presence of a medical condition or surgical procedure that, in the opinion of the PI or designee, may potentially interfere with absorption, distribution, metabolism, or excretion of the study drugs;
- History or presence of alcohol or drug abuse within the past 2 years prior to screening;
- History or presence of hypersensitivity, idiosyncratic reaction, or serious adverse reaction to any of the study drugs or to their formulation excipients;
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 |
|---|---|---|
| itraconazoleParticipants will receive an oral solution as described in the arm description. | Drug | Part 1 |
| rifampinParticipants will receive oral capsule(s) as described in the arm description. | Drug | Part 2 |
| mitapivat sulfateAlso: AG348Participants will receive an oral tablet as described in the arm description. | Drug | Part 1, Part 2 |
Primary outcome
Area Under the Concentration-Time Curve, from Time 0 to the Last Measurable Concentration (AUC0-t) of Mitapivat Sulfate with and without Itraconazole
Time frame: Predose and at various timepoints through 120 hours postdose
Area Under the Concentration-Time Curve, from Time 0 to the Last Measurable Concentration (AUC0-t) of Mitapivat Sulfate with and without Rifampin
Time frame: Predose and at various timepoints through 120 hours postdose
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Mitapivat Sulfate with and without Itraconazole
Time frame: Predose and at various timepoints through 120 hours postdose
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Mitapivat Sulfate with and without Rifampin
Time frame: Predose and at various timepoints through 120 hours postdose
Maximum Observed Plasma Concentration (Cmax) of Mitapivat Sulfate with and without Itraconazole
Time frame: Predose and at various timepoints through 120 hours postdose
Maximum Observed Plasma Concentration (Cmax) of Mitapivat Sulfate with and without Rifampin
Time frame: Predose and at various timepoints through 120 hours postdose
21 secondary outcomes
Area Under the Concentration-Time Curve, from Time 0 to Hour 24 (AUC0-24) of Mitapivat Sulfate and AGI-8702 with and without Itraconazole
Time frame: Predose and at various timepoints through 120 hours postdose
Area Under the Concentration-Time Curve, from Time 0 to Hour 24 (AUC0-24) of Mitapivat Sulfate and AGI-8702 with and without Rifampin
Time frame: Predose and at various timepoints through 120 hours postdose
Percent of AUC0-inf Extrapolated (AUC%extrap) of Mitapivat Sulfate and AGI-8702 with and without Itraconazole
Time frame: Predose and at various timepoints through 120 hours postdose
Percent of AUC0-inf Extrapolated (AUC%extrap) of Mitapivat Sulfate and AGI-8702 with and without Rifampin
Time frame: Predose and at various timepoints through 120 hours postdose
Time of the Last Measurable Concentration (Tlast) of Mitapivat Sulfate and AGI-8702 with and without Itraconazole
Time frame: Predose and at various timepoints through 120 hours postdose
Time of the Last Measurable Concentration (Tlast) of Mitapivat Sulfate and AGI-8702 with and without Rifampin
Time frame: Predose and at various timepoints through 120 hours postdose
Time to Reach Cmax (Tmax) of Mitapivat Sulfate and AGI-8702 with and without Itraconazole
Time frame: Predose and at various timepoints through 120 hours postdose
Time to Reach Cmax (Tmax) of Mitapivat Sulfate and AGI-8702 with and without Rifampin
Time frame: Predose and at various timepoints through 120 hours postdose
Apparent First-Order Terminal Elimination Half-Life (t1/2) of Mitapivat Sulfate and AGI-8702 with and without Itraconazole
Time frame: Predose and at various timepoints through 120 hours postdose
Apparent First-Order Terminal Elimination Half-Life (t1/2) of Mitapivat Sulfate and AGI-8702 with and without Rifampin
Time frame: Predose and at various timepoints through 120 hours postdose
Apparent Volume of Distribution During the Terminal Elimination Phase After Oral (Extravascular) Administration (Vz/F) of Mitapivat Sulfate with and without Itraconazole
Time frame: Predose and at various timepoints through 120 hours postdose
Apparent Volume of Distribution During the Terminal Elimination Phase After Oral (Extravascular) Administration (Vz/F) of Mitapivat Sulfate with and without Rifampin
Time frame: Predose and at various timepoints through 120 hours postdose
Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Mitapivat Sulfate with and without Itraconazole
Time frame: Predose and at various timepoints through 120 hours postdose
Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Mitapivat Sulfate with and without Rifampin
Time frame: Predose and at various timepoints through 120 hours postdose
AUC0-t of AGI-8702 with and without Itraconazole
Time frame: Predose and at various timepoints through 120 hours postdose
AUC0-t of AGI-8702 with and without Rifampin
Time frame: Predose and at various timepoints through 120 hours postdose
AUC0-inf of AGI-8702 with and without Itraconazole
Time frame: Predose and at various timepoints through 120 hours postdose
AUC0-inf of AGI-8702 with and without Rifampin
Time frame: Predose and at various timepoints through 120 hours postdose
Cmax of AGI-8702 with and without Itraconazole
Time frame: Predose and at various timepoints through 120 hours postdose
Cmax of AGI-8702 with and without Rifampin
Time frame: Predose and at various timepoints through 120 hours postdose
Percentage of Participants Experiencing an Adverse Event
Time frame: Baseline up to a maximum of 38 days
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 23 Oct 2019.
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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 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 itraconazole, rifampin and mitapivat sulfate in people with Healthy Volunteers, 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 13 inclusion and 36 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 23 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 the Last Measurable Concentration (AUC0-t) of Mitapivat Sulfate with and without Itraconazole (time frame: Predose and at various timepoints through 120 hours postdose). The study lists 6 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 23 Oct 2019.