A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP4058 Following Single Oral Doses

November 25, 2013 updated by: Astellas Pharma Global Development, Inc.

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacoknetics of ASP4058 Following Single Oral Doses in Healthy Subjects

The purpose of this study is to explore the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of ASP4058 in non-elderly, healthy male and female subjects. This study will also explore the effect of food on the PK of ASP4058.The food-effect crossover group was open-label treatment with no placebo control.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Subjects will remain in the clinic for 9 days. Subjects will return to the clinic for follow-up on days 12 and 30 to collect additional safety information.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33014
        • Clinical Pharmacology of Miami, Inc
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Covance Clinical Research Unit, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The female subject must be at least two years postmenopausal (defined as at least 2 years at Screening without menses and a confirmatory follicle stimulating hormone (FSH) level of ≥ 40 U/L at Screening) or surgically sterile (with documentation provided by a healthcare professional) and not pregnant or lactating.
  • The male subject agrees to sexual abstinence, is surgically sterile (with documentation provided by a healthcare professional), or is using a medically acceptable method (e.g., spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method until end of study or 29 days post-dose, whichever is longer.
  • The subject must have normal (≥ 80% of normal range) respiratory function as defined by spirometry, measuring forced expiratory volume (FEV1) and forced vital capacity (FVC) relative to established normal ranges adjusted for age and sex.
  • The subject at Screening and Day -2, must have color vision testing, acuity testing (corrected), and a fundoscopic exam that are within normal limits in the opinion of the examining/reviewing ophthalmologist.
  • The subject's total lymphocyte count at Screening must be >1.0 x 103/uL.
  • The subject is highly likely to comply with the protocol-defined procedures and complete the study.
  • The subject is positive for herpes simplex virus (HSV)-1 and/or HSV-2 anti-bodies at Screening.

Exclusion Criteria:

  • The subject is a current smoker or has a history of routinely smoking (>10 cigarettes/day) within the last seven years..
  • The subject has a history of clinically significant bradyarrhythmia or sinus bradycardia.
  • The subject has any condition possibly affecting drug absorption (e.g., gastrectomy).
  • The subject has history of consuming more than 14 units of alcoholic beverages per week on average within 6 months prior to Screening or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to Screening or the subject tests positive at Screening or clinic admission for alcohol or drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates).
  • The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 2 weeks prior to clinic check in.
  • The subject has a supine mean systolic blood pressure < 90 or > 140 mmHg and a mean diastolic blood pressure < 50 or > 90 mmHg, or mean heart rate > 100 or < 55 beats per minute (bpm), either at Screening or clinic check in (measurements taken in triplicate after subject has been resting in a supine position for a minimum of 5 minutes).
  • The subject has 12-lead electrocardiogram (ECG) demonstrating QTcF > 450 msec (female) or > 430 msec (male) at Screening. If QTcF exceeds the limits above, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility.
  • The subject has been diagnosed with glaucoma or is currently being treated for glaucoma.
  • The subject is known to be positive for human immunodeficiency virus (HIV) antibody.
  • The subject is currently using Latisse® (eyelash lengthening medication) or has used it within the last 30 days.
  • The subject has a positive test for hepatitis C antibody (HCV), or positive for hepatitis B antigen (HBsAg) at Screening.
  • The subject has used prescription or non-prescription drugs within 2 weeks or 5 half lives (whichever is longer) or complementary and alternative medicines (CAM) within 28 days prior to study drug administration (excluding hormone replacement therapy [HRT] and acetaminophen).
  • The subject has participated in a clinical trial and received an experimental agent or has participated in a clinical trial of approved therapy for investigational use within 30 days or ten half-lives, whichever is longer, prior to study drug administration.
  • The subject has been vaccinated within the last 60 days.
  • The subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or has donated plasma within 7 days prior to clinic admission on Day -2.
  • The subject is known positive for tuberculosis or has tested positive at Screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Oral tablet
Experimental: ASP4058 Tablet Dose Escalation Cohort
Drug: ASP4058
Oral tablet
Experimental: ASP4058 Tablet - Fasting conditions
Drug: ASP4058
Oral tablet
Experimental: ASP4058 Tablet - Fed conditions
Drug: ASP4058
Oral tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameter of ASP4058: Cmax
Time Frame: Day 1-8
Maximum Concentration (Cmax)
Day 1-8
Pharmacokinetic parameter of ASP4058: AUCinf
Time Frame: Day 1-8
Area Under the Concentration - Time curve from time 0 extrapolated to infinity (AUCinf)
Day 1-8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Composite of pharmacokinetic parameters of ASP4058 in plasma: AUClast, Tmax, t1/2, tlag, Vz/F, CL/F
Time Frame: Day 1-8
Area Under the Concentration - Time curve from time 0 up to the last quantifiable concentration (AUClast), Time to Attain Cmax (Tmax), Apparent Terminal Elimination Half-life (t1/2), Time prior to the first measurable (non-zero) concentration (tlag), Apparent Volume of Distribution During the Terminal Phase of the Plasma Concentration vs. Time Profile (Vz/F), Apparent Total Body Plasma Clearance (CL/F)
Day 1-8
Composite of pharmacokinetic parameter of ASP4058 in urine: Aelast, Aelast%, CLr
Time Frame: Day 1-8
Cumulative urine drug excretion from time 0 up to the last measurable concentration (Aelast), Fraction of drug into urine up to the collection time of the last measurable concentration (Aelast%), Renal Clearance (CLr)
Day 1-8
Pharmacodynamics of ASP4058: white blood cell determination with differentials, lymphocyte subsets
Time Frame: Day 1-8
Day 1-8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Global Development, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4058-CL-1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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