Pharmacokinetics of ASP4058Phase 1NCT01998646

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

A Phase 1 study testing ASP4058 in people with Pharmacokinetics of ASP4058 and Healthy Subjects, run by Astellas Pharma Global Development, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Pharmacokinetics of ASP4058, Healthy Subjects, Food Effect of ASP4058
What is being tested?: ASP4058
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 130 participants
Where: 2 sitesUnited States
Study dates: Aug 2010to Jul 2012
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

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.

Who cannot join

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).

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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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Pharmacokinetics of ASP4058, Healthy Subjects, Food Effect of ASP4058
Being tested: ASP4058, Placebo
Keywords: ASP4058, healthy subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ASP4058Drug
Oral tablet
PlaceboDrug
Oral tablet

Study groups in NCT01998646
Study group	Role	What they receive
ASP4058 Tablet Dose Escalation Cohort	Experimental	Not described Receives: Drug: ASP4058
ASP4058 Tablet - Fasting conditions	Experimental	Not described Receives: Drug: ASP4058
ASP4058 Tablet - Fed conditions	Experimental	Not described Receives: Drug: ASP4058
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetic parameter of ASP4058: Cmax
Maximum Concentration (Cmax)
Measured: Day 1-8
Pharmacokinetic parameter of ASP4058: AUCinf
Area Under the Concentration - Time curve from time 0 extrapolated to infinity (AUCinf)
Measured: Day 1-8

Secondary outcomes (3)

Composite of pharmacokinetic parameters of ASP4058 in plasma: AUClast, Tmax, t1/2, tlag, Vz/F, CL/F
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)
Measured: Day 1-8
Composite of pharmacokinetic parameter of ASP4058 in urine: Aelast, Aelast%, CLr
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)
Measured: Day 1-8
Pharmacodynamics of ASP4058: white blood cell determination with differentials, lymphocyte subsets
Measured: Day 1-8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Jul 2012

First posted2 Dec 2013 (estimated)
Study startAug 2010
Primary completionJul 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pharmacokinetics of ASP4058Studies of the same condition, open and under way.
More trials run by Astellas Pharma Global Development, 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01998646
Sponsor's protocol ID: 4058-CL-1001
Status last verified: Nov 2013
First submitted: 25 Nov 2013
Last updated: 2 Dec 2013
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01998646
Acronym / sponsor ID: 4058-CL-1001
Conditions: Pharmacokinetics of ASP4058, Healthy Subjects, Food Effect of ASP4058
Keywords: ASP4058, healthy subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 2 Dec 2013 (estimated)
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.

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 design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
ASP4058 Tablet Dose Escalation Cohort	Experimental	Drug: ASP4058
ASP4058 Tablet - Fasting conditions	Experimental	Drug: ASP4058
ASP4058 Tablet - Fed conditions	Experimental	Drug: ASP4058
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (16 listed)

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.

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
ASP4058Oral tablet	Drug	ASP4058 Tablet - Fasting conditions, ASP4058 Tablet - Fed conditions, ASP4058 Tablet Dose Escalation Cohort
PlaceboOral tablet	Drug	Placebo

Primary outcome

Pharmacokinetic parameter of ASP4058: Cmax
Time frame: Day 1-8
Maximum Concentration (Cmax)
Pharmacokinetic parameter of ASP4058: AUCinf
Time frame: Day 1-8
Area Under the Concentration - Time curve from time 0 extrapolated to infinity (AUCinf)

3 secondary outcomes

Composite of pharmacokinetic parameters of ASP4058 in plasma: AUClast, Tmax, t1/2, tlag, Vz/F, CL/F
Time frame: Day 1-8
Composite of pharmacokinetic parameter of ASP4058 in urine: Aelast, Aelast%, CLr
Time frame: Day 1-8
Pharmacodynamics of ASP4058: white blood cell determination with differentials, lymphocyte subsets
Time frame: Day 1-8

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 2 Dec 2013.

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 Director study director

Astellas Pharma Global Development, Inc.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASP4058 in people with Pharmacokinetics of ASP4058 and Healthy Subjects, run by Astellas Pharma Global Development, Inc. at 2 sites 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 7 inclusion and 16 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 2 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?

Pharmacokinetic parameter of ASP4058: Cmax (time frame: Day 1-8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01998646.

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 2 Dec 2013.