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A study of mirabegron in young children with neurogenic detrusor overactivity

Mirabegron in Young Children Study | Astellas Clinical Trials

A study to learn how [14C]ASP0367 is processed by the body in healthy men

14C ASP0367 In Males Study | Astellas Clinical Trials

A Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Gilteritnib and Chemotherapy Study | Astellas Clinical Trials

A study to find the best dose of ASP5354 to show lymph nodes in people with breast cancer or melanoma during surgery

ASP5354 to Show Lymph Nodes Study | Astellas Clinical Trials

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Intravesical Enfortumab Vedotin for Bladder Cancer Study | Astellas Clinical Trials

A study of the safety and tolerability of ASP7317 in adults who are losing their clear, sharp central vision due to geographic atrophy secondary to dry age-related macular degeneration

ASP7317 for Geographic Atrophy Study | Astellas Clinical Trials

A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants with Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Zolbetuximab Study | Astellas Clinical Trials

A Study of an Intratumoral Oncolytic Virus in Patients with Advanced Metastatic Solid Tumors

Intratumoral Oncolytic Virus Study | Astellas Clinical Trials

A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects with Chronic Tympanic Membrane Perforation (CTMP)

ASP058 Otic Solution Study | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with primary mitochondrial myopathy

ASP0367 Study for Primary Mitochondrial Myopathy | Astellas Clinical Trials

A study of ASP2138 in adults with stomach cancer or pancreatic cancer

ASP2138 Study for Stomach or Pancreatic Cancer | Astellas Clinical Trials

A study about how ASP5354 affects the body in healthy adults and in adults whose kidneys do not work well

ASP5354 for Healthy Adults and Adults with Poor Kidneys | Astellas Clinical Trials

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Prostate Cancer Study for Previous Participation in Enzalutamide  | Astellas Clinical Trials

A Study to Assess the Efficacy and Safety of IMAB362 in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

IMAB362 with Nab P and GEM Study for Pancreatic Cancer  | Astellas Clinical Trials

A study of gilteritinib, venetoclax and azacitidine as a combined treatment for people newly diagnosed with acute myeloid leukemia

Gilteritinib Venetoclax and Azacitidine Study for Acute Myeloid Leukemia | Astellas Clinical Trials

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects with Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

ASP7517 for Acute Myeloid Leukimia | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with reduced maximum oxygen uptake due to poor systemic oxygen extraction

ASP0367 for Reduced Maxiumum Oxygen Uptake Study | Astellas Clinical Trials

A study of ASP3082 in adults with previously treated solid tumors

ASP3082 for Solid Tumors Study | Astellas Clinical Trials

A Study of ASP1570 in adults with locally advanced or metastatic solid tumors

ASP1570 for Advanced or Metastatic Tumors Study | Astellas Clinical Trials

Study of ASP7517 Alone and with Pembrolizumab in Participants with Advanced Solid Tumors Expressing WT1 Antigen

ASP7517 with Pembrolizumab Study | Astellas Clinical Trials

A Safety Surveillance Study in Subjects with Macular Degenerative Disease Treated with Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy

Macular Degenerative Disease Study | Astellas Clinical Trials

A study to evaluate mirabegron in pediatric participants from 5 to less than 18 years of age with overactive bladder (OAB)

Mirabegron Study in Children with OAB Study | Astellas Clinical Trials

Study of ASP0739 Alone and with Pembrolizumab in Advanced Solid Tumors with NY-ESO-1 Expression Participants

ASP0739 with Pembrolizumab Study For Solid Tumors| Astellas Clinical Trials

A study of ASP0367 in people with kidneys that do not work well and in healthy people

ASP0367 Study for Adults with Poor Kidneys | Astellas Clinical Trials

Enfortumab vedotin and pembrolizumab vs. chemotherapy alone in untreated locally advanced or metastatic urothelial cancer

Enfortumab Vedotin and Pembrolizumab vs Chemotherapy Study | Astellas Clinical Trials

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Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on  www.clinicalstudydatarequest.com under “Sponsor Specific Details for Astellas.”

ASP4345 will be administered orally as a single daily dose on days 1 through 14 with water.  On days 1, 7, and 14, ASP4345 will be administered under fasting conditions. On days 2-6 and 8-13, ASP4345 will be administered under fed conditions.

Matching placebo capsules will be administered orally as a single daily dose on days 1 through 14 with water.  On days 1, 7, and 14, matching placebo capsules will be administered with food. On days 2-6 and 8-13, matching placebo will be administered under fed conditions.

ASP4345 will be administered orally as a single daily dose on days 1 through 14 with water.  On days 1, 7, and 14, ASP4345 will be administered  with food. On days 2-6 and 8-13, ASP4345 will be administered under fed conditions.  This is an optional cohort where subjects will be enrolled to further characterize pharmacodynamics in the event a higher sample size is necessary to determine changes in electrophysiological biomarkers.

4345-CL-0002 Redacted CSR synopsis.pdf

4345-CL-0002 Plain language summary.pdf

The purpose of this study is to evaluate the safety and tolerability of multiple ascending oral doses of ASP4345 in patients with schizophrenia.  In addition, this study will evaluate the pharmacokinetics of multiple ascending oral doses of ASP4345 in patients with schizophrenia.

A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP4345 in Patients with Schizophrenia

CN CDE Number

EudraCT Number

jRCT Number

NCT ID

Patient Level Data

Product ST Name

Therapeutic Area

Link to results on the Astellas Clinical Study Results website.

Site US10001

A Phase 1 Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP4345 in Patients with Schizophrenia

Incidence of positive orthostatic challenge tests will be summarized.

Clinical laboratory tests include hematology, biochemistry and urinalysis.

The overall interpretation of 12-lead electrocardiogram (ECG) results (normal, abnormal not clinically significant and abnormal clinically significant) will be summarized.

ECGs will be collected using a 12-lead ECG continuous monitoring system which records continuous digital data.

ARCI-49 is a 49-item short form standardized questionnaire for abuse potential liability.

The C-SSRS is a scale that assesses the full spectrum of suicidality: suicidal ideation, intensity of ideation, suicidal behaviors and actual attempts.

The VAS will be used to rate patients’ feelings in terms of 16 dimensions.  The dimensions will be presented as 100 mm lines, the 2 extremes of the emotion (i.e., alert – drowsy) written at each end.

The AIMS is a checklist and uses a 5-point rating scale for recording scores for 7 body areas: face, lips, jaw, tongue, upper extremities, lower extremities and trunk.

The SAS is a 10-item scale used to rate adverse neurological effects of antipsychotic medications more broadly.  Each item is rated from 0 to 4 and a total score will be obtained.

The BARS is a rating scale used to assess the severity of drug-induced akathisia.

Time prior to the time corresponding to the first measurable (nonzero) concentration (tlag)

Area under the concentration-time curve from the time of dosing to the start of the next dosing interval (AUCtau)

Concentration immediately prior to dosing at multiple dosing (Ctrough)

Mean residence time extrapolated to time infinity (MRTinf)

Apparent volume of distribution during the terminal elimination phase after single extravascular dosing (Vz/F)

Apparent total systemic clearance after extravascular dosing (CL/F)

Accumulation index area under the concentration-time curve (Rac(AUC))

Cumulative amount of study drug excreted into urine from the time of dosing to the start of the next dosing interval (Aetau)

Percentage of study drug dose excreted into urine from the time of dosing to the start of the next dosing interval (Aetau%)