Healthy Subjects Clinical Trial
Official title:
A Phase 1, Open-Label, Sequential Study of the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Mycophenolate Mofetil in Healthy Adult Subjects
Verified date | October 2012 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of mycophenolate mofetil (MMF) after single dose administration. Safety and tolerability of isavuconazole will be assessed alone and in combination with MMF.
Status | Completed |
Enrollment | 24 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - The subject has a body weight of at least 45 kg and has a body mass index (BMI) of 18 to 32 kg/m2, inclusive. - Results for aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be = 1.5 mg/dL - The female subject agrees to sexual abstinence, or is surgically sterile, postmenopausal (defined as at least 2 years at Screening without menses), or using a medically acceptable double barrier method (e.g. spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method from Screening until 5 weeks after the follow-up visit at the end of the study; and is not lactating or pregnant as documented by negative pregnancy tests at Screening and Day -1. - The male subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method from Screening until 5 weeks after the follow-up visit at the end of the study Exclusion Criteria: - The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes). - The subject has a history of tuberculosis or exposure to anyone known or suspected to have tuberculosis or any illness that might confound the results of the study or pose additional risk in administering study drug to the subject. - The subject has a positive result for hepatitis C antibodies, hepatitis B surface antigen, or QuantiFERON®-TB Gold test at Screening or is known to be positive for human immunodeficiency virus (HIV). - The subject has a known or suspected allergy to any of the components of the trial products including mycophenolate mofetil (MMF) or the azole class of compounds, or a history of multiple and/or severe allergies to drugs or foods, or a history of severe anaphylactic reactions. - The subject is a smoker (any use of tobacco or nicotine containing products) within 6 months prior to Screening. - The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Day -1, or over-the-counter medications within 1 week prior to Day -1, with the exception of acetaminophen up to 2 g/day. - The subject has a recent history (within the last 2 years) of drug or alcohol abuse, as defined by the investigator, or a positive drug and/or alcohol screen |
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | Parexel International, LLC | Glendale | California |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Global Development, Inc. | Basilea Pharmaceutica International Ltd |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite of pharmacokinetic (PK) variables of plasma mycophenolic acid (MPA) and phenolic glucuronide of MPA (MPAG): AUClast, AUCinf, Cmax | Area under the concentration-time curve (AUC) from the time of dosing to the last quantifiable concentration (AUClast), AUC from the time of dosing to infinity (AUCinf), and maximum concentration (Cmax) | Days 1 and 13: predose, and at 0.5, .75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, and 96 hours postdose | No |
Secondary | PK of plasma isavuconazole: Trough concentration (Ctrough) | Day 11, Days 14-16, predose and on Day 17, predose and 24 hours postdose | No | |
Secondary | Composite of PK variables of plasma isavuconazole concentration: AUCtau, Cmax, and tmax | AUC during the time interval between consecutive dosing (AUCtau), time to attain Cmax (tmax) | Days 12 and 13: predose and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, and 24 hours postdose | No |
Secondary | Composite of PK variables of plasma MPA: tmax, t1/2, Vz/F, and CL/F | Apparent terminal elimination half-life (t1/2), apparent volume of distribution (Vz/F), and apparent body clearance after oral dosing (CL/F) | Days 1 and 13: predose, and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, and 96 hours postdose | No |
Secondary | Composite of PK variables of plasma MPAG: tmax and t1/2 | Days 1 and 13: predose, and at 0.5, .75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, and 96 hours postdose | No | |
Secondary | Safety assessed through the reporting of adverse events, laboratory evaluations, electrocardiograms (ECGs) and vital signs | Through Day 17 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05483998 -
A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants
|
Phase 1 | |
Recruiting |
NCT02417714 -
Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
|
||
Recruiting |
NCT02235012 -
Cognitive Biases Under Ketamine
|
N/A | |
Completed |
NCT04418973 -
Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject.
|
N/A | |
Completed |
NCT05088343 -
Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects
|
Phase 1 | |
Not yet recruiting |
NCT06248801 -
Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets
|
Phase 1 | |
Terminated |
NCT04068259 -
Single Ascending Dose Study of PBI-4547 in Healthy Subjects
|
Phase 1 | |
Completed |
NCT03279302 -
Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects
|
Phase 1 | |
Not yet recruiting |
NCT06233162 -
Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets
|
Phase 1 | |
Recruiting |
NCT04159844 -
Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects
|
N/A | |
Completed |
NCT06137911 -
Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults.
|
Phase 1 | |
Completed |
NCT04849286 -
Measurement of HTL0016878 in Cerebrospinal Fluid
|
Phase 1 | |
Not yet recruiting |
NCT06233227 -
Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule
|
Phase 1 | |
Completed |
NCT04096157 -
A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants
|
Phase 1 | |
Completed |
NCT01200368 -
Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
|
Phase 3 | |
Recruiting |
NCT05805033 -
Peri-Implant Soft Tissue Integration in Humans: Influence of Material
|
N/A | |
Completed |
NCT04027803 -
Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®
|
Phase 1 | |
Recruiting |
NCT03467880 -
Multicenter Study of Impulse Oscillometry in Chinese
|
N/A | |
Completed |
NCT02903095 -
Single Ascending Dose Study of TD-1439 in Healthy Subjects
|
Phase 1 | |
Active, not recruiting |
NCT02341508 -
A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers
|
Phase 1 |