Healthy VolunteersPhase 1MADNCT02136316

A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Multiple Ascending Doses of ASP7962 in Healthy Subjects

A Phase 1 study testing ASP7962 in people with Healthy Volunteers and Pharmacokinetics of ASP7962, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.

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

The purpose of this study is to evaluate the safety and tolerability as well as the pharmacokinetics of increasing oral multiple doses of ASP7962 in healthy young male and female subjects. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers, Pharmacokinetics of ASP7962
What is being tested?: ASP7962
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteUnited Kingdom
Study dates: May 2014to Nov 2015
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

Subject has a body mass index of 18.5 - 30.0 kg/m2, inclusive. Subject weighs at least 50 kg.
Female subject must be of non-childbearing potential:
Postmenopausal (defined as at least 1 year without any menses and confirmation of FSH levels) prior to screening, or
Documented surgically sterile or status post-hysterectomy (at least 1 month prior to screening).
Male subject and their female spouse/partner who are of childbearing potential must be using 2 highly effective forms of birth control (1 of which must be a barrier method) starting at screening and continued throughout the clinical study period, and for 90 days after the final study drug administration.
Male subject must not donate sperm starting at screening, throughout the clinical study period, and for 90 days after the final study drug administration.
Subject agrees not to participate in another interventional study while participating in the present clinical study, defined as signing the informed consent form until completion of the last study visit.

Who cannot join

Subject has a known or suspected hypersensitivity to ASP7962 or any components of the formulation used.
Subject has a history of suicide attempt or suicidal behavior. Any suicidal ideation within the last 3 months.
Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, gamma glutamyl transferase, total bilirubin [TBL]) above the upper limit of normal [ULN]. In such a case the assessment may be repeated once [day -1].
Subject has any clinically significant history of allergic conditions.
Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to admission to the clinical unit on day -1.
Subject has a mean pulse rate < 40 or > 90 bpm; mean systolic blood pressure (SBP) > 140 mmHg; mean diastolic blood pressure (DPB) > 90 mmHg (vital sign measurements taken in triplicate after subject has been resting in supine position for 5 minutes; pulse rate will be measured automatically) [day -1]. If the mean pulse rate, mean SBP or mean DBP is out of the range as specified above, 1 additional triplicate measurement may be taken on day -1.

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Subject has a mean corrected QT interval using Fridericia's formula (QTcF) interval > 430 ms (for male subjects) and > 450 ms (for female subjects) on admission to the clinical unit on day 1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG can be taken [day -1].
Subject uses any prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g., St. John's wort) in the 2 weeks prior to study drug administration, except for occasional use of paracetamol (up to 2 g/day).
Subject has used nicotine-containing products within 6 months prior to admission to the clinical unit.
Subject has a history of drinking more than 21 units of alcohol per week for male subjects or 14 units of alcohol per week for female subjects (1 unit = 10 g pure alcohol = 250 mL of beer [5%] or 35 mL of spirits [35%] or 100 mL of wine [12%]) within 3 months prior to admission to the clinical unit.
Subject uses any drugs of abuse within 3 months prior to admission to the clinical unit.
Subject uses any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to admission to the clinical unit.
Subject has had a significant blood loss, donated 1 unit (500 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to admission to the clinical unit.
Subject has a positive serology test for hepatitis B surface antigen, hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies, or antibodies to human immunodeficiency virus type 1 (HIV-1) and/or type 2 (HIV-2) at screening.
Subject has participated in any clinical study or has been treated with any investigational drugs within 28 days or 5 half-lives, whichever is longer, prior to screening.
Subject is an employee of the Astellas Group or Contract Research Organization involved in the clinical study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Site GB44001 Parexel Early Phase Clinical Unit
London, HA13UJ

Other trials in United Kingdom

About this study

Official title: A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Oral Multiple Doses of ASP7962 in Healthy Male and Female Subjects

The purpose of this study is to evaluate the safety and tolerability as well as the pharmacokinetics of increasing oral multiple doses of ASP7962 in healthy young male and female subjects.

Read the detailed description

Subjects will be admitted to the clinical unit and will stay residential for a total of 20 days/19 nights, to be discharged from the clinical unit on day 19.

Conditions: Healthy Volunteers, Pharmacokinetics of ASP7962
Being tested: ASP7962, Placebo
Keywords: Healthy volunteers, ASP7962, pharmacokinetics

What participants receive

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

ASP7962Drug
Oral
PlaceboDrug
Oral

Study groups in NCT02136316
Study group	Role	What they receive
ASP7962 low dose	Experimental	Not described Receives: Drug: ASP7962
ASP7962 medium dose	Experimental	Not described Receives: Drug: ASP7962
ASP7962 high dose	Experimental	Not described Receives: Drug: ASP7962
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.

Safety as assessed by adverse events
Measured: up to end of study visit (29 days)
Safety as assessed by vital signs
Measured: up to end of study visit (29 days)
Safety as assessed by orthostatic challenge test
Measured: Day 1 and 16
Safety as assessed by clinical laboratory tests
Measured: up to end of study visit (29 days)
Safety as assessed by electrocardiogram (ECG)
Routine 12-lead ECG, continuous cardiac monitoring (Holter ECG) and real-time cardiac monitoring (ECG telemetry)
Measured: up to end of study visit (29 days)
Safety as assessed by Bond and Lader visual analogue scale (VAS)
Measured: Day 3-19
Safety as assessed by Addiction Research Center Inventory (ARCI)-49 (49-item)
Measured: Day 3-19
Safety as assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
Measured: Day 2-19
Safety as assessed by CogState cognitive test battery: Groton Maze Learning Task, Groton Maze Learning Task-Delayed Recall, Detection Task, Identification Task, One Card Learning Task, One Back Task
Measured: Day 3-19

Secondary outcomes (4)

Pharmacokinetic profile of ASP7962 (plasma): AUC12, AUC12,u, AUCinf, AUCinf,u , AUClast, AUClast,u, CL/F, CLu/F, Cmax
Area under the concentration-time curve from the time of dosing to 12 hours postdose (AUC12), Area under the concentration-time curve from the time of dosing to 12 hours postdose for unbound study drug concentration (AUC12,u), Area under the concentration-time curve from time of dosing extrapolated to time infinity (AUCinf), Area under the concentration-time curve from time of dosing extrapolated to time infinity for unbound study drug concentration (AUCinf, u), Area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast), Area under the concentration-time curve from the time of dosing to the last measurable unbound concentration (AUClast, u), Apparent total systemic clearance after single or multiple extravascular dosing (CL/F), Apparent total systemic clearance of unbound study drug after single or multiple extravascular dosing (CLu/F), Maximum concentration (Cmax)
Measured: up to Day 19
Pharmacokinetic profile of ASP7962 (plasma): Cmax,u, MRT, t1/2, tmax, tlag, λz, fu, AUCinf,u/AUCinf , Vz/F
Maximum unbound concentration (Cmax,u), Mean residence time (MRT), Terminal elimination half-life (t1/2), Time of maximum concentration (tmax), Time prior to the time corresponding to the first measurable (nonzero) concentration (tlag), Terminal elimination rate constant (λz), Fraction of study drug available systematically unbound (= free fraction) (fu), Apparent volume of distribution during the terminal elimination phase after single or multiple extravascular dosing (Vz/F)
Measured: up to Day 19
Pharmacokinetic profile of ASP7962 (plasma): Ctrough, AUCtau, Rac(AUC), Rac(Cmax), PTR, Ratio AUCu/AUC, Vz,u/F, AUCtau,u
Concentration immediately prior to dosing at multiple dosing (Ctrough), Area under the concentration-time curve from the time of dosing to the start of the next dosing interval (AUCtau), Accumulation ratio calculated using the area under the concentration-time curve (Rac[AUC]), Accumulation ratio calculated using the maximum plasma concentration (Rac[Cmax]), Peak-trough ratio (PTR), Apparent volume of distribution during the terminal elimination phase of unbound study drug after single or multiple extravascular dosing (VZ,u/F), Area under the concentration-time curve in the dosing interval for unbound study drug concentration (AUCtau,u)
Measured: up to Day 19
Pharmacokinetic profile of ASP7962 (urine): Aeinf, Aeinf%, Aelast, Aelast%, CLR, CLR,u, Aetau, Aetau%
Cumulative amount of study drug excreted into urine from time of dosing extrapolated to time infinity (Aeinf), Percentage of study drug excreted into urine from time of dosing extrapolated to time infinity (Aeinf%), Cumulative amount of study drug excreted into urine from time of dosing up to the collection time of the last measurable concentration (Aelast), Percentage of study drug excreted into urine from the time of dosing up to the collection time of the last measurable concentration (Aelast%), Renal clearance (CLR), Renal clearance of unbound study drug (CLR,u), 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 over the time interval between consecutive dosing (Aetau%)
Measured: Day 1 and 16

Timeline

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

May 2014Nov 2015

First posted13 May 2014 (estimated)
Study startMay 2014
Primary completionNov 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
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
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02136316
Sponsor's protocol ID: 7962-CL-0002
Other IDs: 2014-000159-95, 2014
Acronym: MAD
Status last verified: Dec 2015
First submitted: 9 May 2014
Last updated: 15 Dec 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Oral Multiple Doses of ASP7962 in Healthy Male and Female Subjects
ClinicalTrials.gov ID: NCT02136316
Acronym / sponsor ID: MAD / 7962-CL-0002
Conditions: Healthy Volunteers, Pharmacokinetics of ASP7962
Keywords: Healthy volunteers, ASP7962, pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
Study start: May 2014
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 13 May 2014 (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.

The purpose of this study is to evaluate the safety and tolerability as well as the pharmacokinetics of increasing oral multiple doses of ASP7962 in healthy young male and female subjects.

Detailed description

Subjects will be admitted to the clinical unit and will stay residential for a total of 20 days/19 nights, to be discharged from the clinical unit on day 19.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
ASP7962 low dose	Experimental	Drug: ASP7962
ASP7962 medium dose	Experimental	Drug: ASP7962
ASP7962 high dose	Experimental	Drug: ASP7962
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)

Subject has a body mass index of 18.5 - 30.0 kg/m2, inclusive. Subject weighs at least 50 kg.
Female subject must be of non-childbearing potential:
Male subject and their female spouse/partner who are of childbearing potential must be using 2 highly effective forms of birth control (1 of which must be a barrier method) starting at screening and continued throughout the clinical study period, and for 90 days after the final study drug administration.
Male subject must not donate sperm starting at screening, throughout the clinical study period, and for 90 days after the final study drug administration.
Subject agrees not to participate in another interventional study while participating in the present clinical study, defined as signing the informed consent form until completion of the last study visit.

Key exclusion criteria (16 listed)

Subject has a known or suspected hypersensitivity to ASP7962 or any components of the formulation used.
Subject has a history of suicide attempt or suicidal behavior. Any suicidal ideation within the last 3 months.
Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, gamma glutamyl transferase, total bilirubin [TBL]) above the upper limit of normal [ULN]. In such a case the assessment may be repeated once [day -1].
Subject has any clinically significant history of allergic conditions.
Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to admission to the clinical unit on day -1.

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
ASP7962Oral	Drug	ASP7962 high dose, ASP7962 low dose, ASP7962 medium dose
PlaceboOral	Drug	Placebo

Primary outcome

Safety as assessed by adverse events
Time frame: up to end of study visit (29 days)
Safety as assessed by vital signs
Time frame: up to end of study visit (29 days)
Safety as assessed by orthostatic challenge test
Time frame: Day 1 and 16
Safety as assessed by clinical laboratory tests
Time frame: up to end of study visit (29 days)
Safety as assessed by electrocardiogram (ECG)
Time frame: up to end of study visit (29 days)
Routine 12-lead ECG, continuous cardiac monitoring (Holter ECG) and real-time cardiac monitoring (ECG telemetry)
Safety as assessed by Bond and Lader visual analogue scale (VAS)
Time frame: Day 3-19
Safety as assessed by Addiction Research Center Inventory (ARCI)-49 (49-item)
Time frame: Day 3-19
Safety as assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
Time frame: Day 2-19
Safety as assessed by CogState cognitive test battery: Groton Maze Learning Task, Groton Maze Learning Task-Delayed Recall, Detection Task, Identification Task, One Card Learning Task, One Back Task
Time frame: Day 3-19

4 secondary outcomes

Pharmacokinetic profile of ASP7962 (plasma): AUC12, AUC12,u, AUCinf, AUCinf,u , AUClast, AUClast,u, CL/F, CLu/F, Cmax
Time frame: up to Day 19
Pharmacokinetic profile of ASP7962 (plasma): Cmax,u, MRT, t1/2, tmax, tlag, λz, fu, AUCinf,u/AUCinf , Vz/F
Time frame: up to Day 19
Pharmacokinetic profile of ASP7962 (plasma): Ctrough, AUCtau, Rac(AUC), Rac(Cmax), PTR, Ratio AUCu/AUC, Vz,u/F, AUCtau,u
Time frame: up to Day 19
Pharmacokinetic profile of ASP7962 (urine): Aeinf, Aeinf%, Aelast, Aelast%, CLR, CLR,u, Aetau, Aetau%
Time frame: Day 1 and 16

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 15 Dec 2015.

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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 Monitor study director

Astellas Pharma Europe B.V.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASP7962 in people with Healthy Volunteers and Pharmacokinetics of ASP7962, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.

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 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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?

Safety as assessed by adverse events (time frame: up to end of study visit (29 days)). The study lists 9 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 NCT02136316.

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 15 Dec 2015.