Healthy Volunteers Clinical Trial
Official title:
A 2-Stage, Open-Label, Randomized, Single-Dose, Crossover Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of Entinostat in Healthy Adult Subjects
Verified date | August 2018 |
Source | Syndax Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objectives of this study are to evaluate the effect of the timing of a moderate-fat meal on the single dose pharmacokinetics of entinostat and to evaluate the safety and tolerability of entinostat under fed and fasting conditions in healthy adult subjects.
Status | Completed |
Enrollment | 47 |
Est. completion date | June 26, 2017 |
Est. primary completion date | May 20, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Healthy adults 19-55 years of age at screening. - Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to first dose and throughout the study. - Body mass index of = 18.5 at screening. - Medically healthy with no significant medical history, physical examination, laboratory values, vital signs, or ECGs. Liver function tests and serum bilirubin must be = the upper limit of normal. Platelets, hemoglobin, and hematocrit must be > the lower limit of normal at screening. - Females of non-childbearing potential must have undergone sterilization procedures as noted in protocol at least 6 months prior to dose. - Non-vasectomized male subjects must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond dose of study drug. - Male subjects must agree not to donate sperm from the first dose until 90 days beyond dose of study drug. - Understands the study procedures in the informed consent form and be willing and able to comply with the protocol. Exclusion Criteria: - Mentally or legally incapacitated or has significant emotional problems at screening 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 PI or designee. - History of illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study in the opinion of the PI or designee. - History of presence of alcoholism or drug abuse within the past 2 years prior to dose. - History or presence of clinically significant cancer, cardiovascular disorders, acute or chronic gastrointestinal conditions in the opinion of the PI. - Females of childbearing potential. - Females with a positive pregnancy test or lactating. - Positive urine drug or alcohol results are screening or each check-in. - Positive urine cotinine at screening. - Positive results are screening for HIV, hepatitis B surface antigen, or hepatitis C virus - Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening. - Seated heart rate lower than 40 bpm or higher than 99 bpm at screening. - QTcB interval (correction value of the interval between the Q and T waves on the ECG tracing using the Bazett Correction Formula) > 460 msec for males or > 480 msec for females or has ECG findings deemed abnormal by the PI or designee. - Estimated creatinine clearance < 90 mL/min at screening. - Unable to refrain from or anticipates the use of any prescription or non-prescription medications and any drugs known to be significant inhibitors or CYP (Cytochromes 450) enzymes and/or P-gp. - Has been on a diet incompatible with the on-study diet within 28 days prior to dose and throughout the study in the opinion of the PI or designee. - Is lactose intolerant. - Donation of blood or significant blood loss within 56 days prior to dose. - Plasma donation within 7 days prior to dose. - Participation in another clinical study 28 days prior to dose. |
Country | Name | City | State |
---|---|---|---|
United States | Celerion | Lincoln | Nebraska |
Lead Sponsor | Collaborator |
---|---|
Syndax Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AUC0-t (area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) for entinostat under fed and fasting conditions | Pre-dose through Day 22 | ||
Primary | AUC0-inf (area under the concentration-time curve, from time 0 extrapolated to infinity) for entinostat under fed and fasting conditions | Pre-dose through Day 22 | ||
Primary | Cmax (maximum observed concentration) of entinostat under fed and fasting conditions | Pre-dose through Day 22 | ||
Primary | AUC%extrap (percent of AUC0-inf extrapolated) of entinostat under fed and fasting conditions | Pre-dose through Day 22 | ||
Primary | Tmax (time to reach maximum observed concentration) of entinostat under fed and fasted conditions | Pre-dose through Day 22 | ||
Primary | Kel (apparent terminal elimination rate constant) of entinostat under fed and fasted conditions | Pre-dose through Day 22 | ||
Primary | T1/2 (apparent terminal elimination half-life) of entinostat under fed and fasted conditions | Pre-dose through Day 22 | ||
Primary | Changes from baseline in physical exam | Baseline through Day 1 | ||
Primary | Changes from baseline in vital signs | Baseline through Day 22 | ||
Primary | Changes from baseline in ECG results | Baseline through Day 22 | ||
Primary | Changes from baseline in adverse events | Baseline through 14 days after last sample collection | ||
Primary | Changes from baseline in clinical laboratory tests | Baseline through Day 1 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05001152 -
Taste Assessment of Ozanimod
|
Phase 1 | |
Completed |
NCT05029518 -
3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability
|
Phase 1 | |
Completed |
NCT04493255 -
A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants
|
Phase 1 | |
Completed |
NCT03457649 -
IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT00995891 -
Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
|
||
Completed |
NCT05043766 -
Evaluation of Oral PF614 Relative to OxyContin
|
Phase 1 | |
Completed |
NCT05050318 -
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
|
Phase 4 | |
Completed |
NCT04466748 -
A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects
|
Phase 1 | |
Completed |
NCT00746733 -
Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC
|
Phase 1 | |
Recruiting |
NCT05929651 -
Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy
|
Phase 4 | |
Completed |
NCT05954039 -
Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect
|
N/A | |
Completed |
NCT05045716 -
A Study of Subcutaneous Lecanemab in Healthy Participants
|
Phase 1 | |
Active, not recruiting |
NCT02747927 -
Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
|
Phase 3 | |
Completed |
NCT05533801 -
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
|
Phase 1 | |
Not yet recruiting |
NCT03931369 -
Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST)
|
Phase 2 | |
Completed |
NCT03279146 -
A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects
|
Phase 1 | |
Completed |
NCT06027437 -
A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
|
Phase 1 | |
Recruiting |
NCT05619874 -
Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity
|
N/A | |
Completed |
NCT05553418 -
Investigational On-body Injector Clinical Study
|
N/A | |
Completed |
NCT04092712 -
Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers
|
Phase 1 |