Healthy VolunteersPhase 1NCT03108755

A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP7713 in Healthy Non-Japanese Adult and Elderly Subjects and Healthy Japanese Adult Subjects

A Phase 1 study testing ASP7713 in people with Healthy Volunteers, 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

This is a combined Single and Multiple Ascending Oral Dose Study. Part 1 is a Single Ascending Dose (SAD) and Part 2 is Multiple Ascending Dose (MAD). The purpose of the study is to evaluate the safety and tolerability of single and multiple ascending oral doses of ASP7713 in healthy non-Japanese (Part 1) and Japanese… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: ASP7713
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited Kingdom
Study dates: 23 May 2017to 25 Aug 2017
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject is a healthy non-Japanese adult male or female subject between 18 to 55 years of age, inclusive, at screening or subject is a healthy non-Japanese elderly male or female subject, ≥ 65 years of age and has a body mass index (BMI) range of 18.5 to 30.0 kg/m2, inclusive and weighs at least 50 kg at screening and day -1 OR Subject is a healthy Japanese adult male or female subject between 20 to 55 years of age, inclusive, at screening and has a BMI range of 18.0 to 28.0 kg/m2, inclusive and weighs at least 45 kg at screening and day -1.
In case of Japanese subject: subject is from Japanese origin. Both parents and all 4 grandparents should be Japanese. The subject should have been born in Japan and should not have lived outside of Japan for more than 10 years.
Female subject must either:
Be of nonchildbearing potential: Postmenopausal (defined as at least 1 year without any menses) prior to screening, or Documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy) Or, if of childbearing potential, Agree not to try to become pregnant during the study and for 28 days after the final study drug administration, And have a negative pregnancy test at day -1, And if heterosexually active, agree to consistently use 2 forms of birth control (1 of which is a highly effective method and 1 must be a barrier method) starting at screening and throughout the study period and for 28 days after the final study drug administration.
Female subject must agree not to breastfeed starting at screening and throughout the study period and for 28 days after the final study drug administration.
Female subject must not donate ova starting at screening and throughout the study period and for 28 days after the final study drug administration.

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A sexually active male subject with female partner(s) who are of childbearing potential is eligible if:
Male subject agrees to use a male condom starting at screening and continue throughout study treatment and for 28 days after the final study drug administration.
Male subject must not donate sperm starting at screening and throughout the study period and for 28 days after the final study drug administration.
Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a male condom for the duration of the pregnancy or for the time the partner is breastfeeding throughout the study period and for 28 days after the final study drug administration.
Subject agrees not to participate in another interventional study while participating in the present study.

Who cannot join

Subject has received investigational therapy within 28 days (or 5 half-lives, whichever is longer) prior to screening.
Subject has any condition which makes the subject unsuitable for study participation.
Female subject who has been pregnant within 6 months prior to screening assessment or breast feeding within 3 months prior to screening.
Subject has a known or suspected hypersensitivity to ASP7713, or any components of the formulation used.
Subject has had previous exposure with ASP7713.
Subject has any of the liver function tests (LFTs) (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, gamma-glutamyl transferase and total bilirubin [TBL]) above the upper limit of normal (ULN) at day -1. In such a case, the assessment may be repeated once.

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Subject has any of the cardiac troponins (cardiac troponin T [cTnT] and cardiac troponin I [cTnI]) above the ULN at day -1. In such a case, the assessment may be repeated once.
Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to study drug administration.
Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy.
Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (noncutaneous) infection within 1 week prior to day -1.
Subject has any clinically significant abnormality following the investigator's review of the physical examination, electrocardiogram (ECG) and protocol-defined safety laboratory tests at screening or day -1.
Subject has a mean pulse < 45 or > 90 bpm; mean systolic blood pressure < 90 or > 140 mmHg; mean diastolic blood pressure < 50 or > 90 mmHg (measurements taken in triplicate after subject has been resting in supine position for 5 minutes; pulse will be measured automatically) at screening or day -1. If the mean blood pressure exceeds the limits above, 1 additional triplicate can be taken.
Subject has a mean QTcF interval of > 430 msec (for males) and > 450 msec (for females) at screening or day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG can be taken.
Subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of long QT syndrome.
Subject has used any prescribed or nonprescribed 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) and except for use of hormonal contraceptives and hormone replacement therapy.
Subject has smoked or has used tobacco-containing products and nicotine or nicotine-containing products in the past 6 months prior to screening.
Subject has a history of drinking more than 21 units of alcohol per week (1 unit = 10 g pure alcohol = 250 mL of beer [5%] or 35 mL of spirits [35%] or 100 mL of wine [12%]) (> 14 units of alcohol for female subjects) within 3 months prior to day -1 or the subject tests positive for alcohol or drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) at screening or day -1.
Subject has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) within 3 months prior to day -1.
Subject has consumed grapefruit/Seville oranges, grapefruit-containing products or Seville orange-containing products within 72 hours prior to admission to the clinical unit.
Subject has used any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to day -1.
Subject has had significant blood loss, donated 1 unit (450 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 day -1.
Subject has a positive serology test for hepatitis B surface antigen, hepatitis B core antibody, hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies, or antibodies to human immunodeficiency virus type 1 and/or type 2 at screening.
Subject is an employee of the Astellas Group or contract research organization.
Subject has a history of orthostatic hypotension or a positive orthostatic challenge test which is based on the measurements 3 minutes after standing:
Systolic blood pressure (SBP) ≥ 20 mmHg decrease from supine and/or
Diastolic blood pressure (DBP) ≥ 10 mmHg decrease from supine at screening or day -1.
Subject has any clinically significant abnormalities on cardiac imaging at screening.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Site GB44001
Harrow, Middlesex, HA 1 3UJ

Other trials in United Kingdom

About this study

Official title: A Phase 1 Combined Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP7713 in Healthy Non-Japanese Adult and Elderly Subjects and Healthy Japanese Adult Subjects

This is a combined Single and Multiple Ascending Oral Dose Study. Part 1 is a Single Ascending Dose (SAD) and Part 2 is Multiple Ascending Dose (MAD).

The purpose of the study is to evaluate the safety and tolerability of single and multiple ascending oral doses of ASP7713 in healthy non-Japanese (Part 1) and Japanese (Part 2) adult participants and non-Japanese elderly participants (Part 2).

This study will also evaluate the pharmacokinetics of single and multiple ascending oral doses of ASP7713 in non-Japanese (Part1) and Japanese (Part 2) adult participants and non-Japanese elderly participants (Part 2) as well as the effect of a single and multiple oral dose of ASP7713 on the QT interval using Fridericia's Correction (QTcF).

In addition, this study will evaluate a potential racial difference in safety, tolerability and pharmacokinetics of multiple oral doses of ASP7713 in healthy non-Japanese and Japanese adult participants (Part 2).

Read the detailed description

There will be a residential period for Parts 1 and 2. Part 1: Eligible participants will be residential for a single period of 5 days and 4 nights. Participants will be discharged on day 4 on the condition that all required assessments have been performed and that there are no medical reason for a longer stay in the clinical unit.

Part 2: Eligible participants will be residential for a single period of 18 days and 17 nights. Participants will be discharged on day 17 on the condition that there are no medical reason for a longer stay in the clinical unit.

Conditions: Healthy Volunteers
Being tested: ASP7713, Placebo
Keywords: ASP7713

What participants receive

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

ASP7713Drug
oral
PlaceboDrug
oral

Study groups in NCT03108755
Study group	Role	What they receive
ASP7713 Single Ascending Dose	Experimental	Successive cohorts of 8 non-Japanese participants (6 ASP7713/ 2 Placebo / 1-7 cohorts) will be started on a fixed single dose of ASP7713 or matching Placebo. The first two participants will receive either ASP7713 or matching placebo. If no safety issues are observed in the first 24 hours in the first two participants, then the remaining six participants will be dosed. Safety, tolerability and available Pharmacokinetic data from proceeding cohorts will be assessed for dose escalation. Receives: Drug: ASP7713
Placebo Single Ascending Dose	Placebo comparator	Successive cohorts of 8 non-Japanese participants (6 ASP7713/ 2 Placebo / 1-7 cohorts) will each be started on a single fixed dose of ASP7713 or matching Placebo. The first two participants will receive either ASP7713 or matching placebo. If no safety issues are observed in the first 24 hours in the first two participants, then the remaining six participants will be dosed. Safety, tolerability and available Pharmacokinetic data from proceeding cohorts will be assessed for dose escalation. Receives: Drug: Placebo
ASP7713 Multiple Ascending Dose (Adults: 18-55 years)	Experimental	Successive cohorts of 16 participants consisting of 8 non-Japanese and 8 Japanese (12 ASP7713/ 4 Placebo /1-3 cohorts) will each be started on a fixed multiple dose of ASP7713 or matching Placebo twice or three times daily for 14 days. Safety, tolerability and available Pharmacokinetic data from proceeding cohorts will be assessed for dose escalation. Receives: Drug: ASP7713
Placebo Multiple Ascending Dose (Adults: 18-55 years)	Placebo comparator	Successive cohorts of 16 participants consisting of 8 non-Japanese and 8 Japanese (12 ASP7713/ 4 Placebo /1-3 cohorts) will each be started on a fixed multiple dose of ASP7713 or matching Placebo twice or three times daily for 14 days. Safety, tolerability and available Pharmacokinetic data from proceeding cohorts will be assessed for dose escalation. Receives: Drug: Placebo
ASP7713 Multiple Ascending Dose (Elderly: 65 years or older)	Experimental	Dosing of the non-Japanese elderly cohort will commence after having established the safety and tolerability of corresponding dose in adults male and female participants. Receives: Drug: ASP7713
Placebo Multiple Ascending Dose (Elderly: 65 years or older)	Placebo comparator	Dosing of the non-Japanese elderly cohort will commence after having established the safety and tolerability of corresponding dose in adults male and female participants. Receives: Drug: Placebo

What is being measured

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

Safety as assessed by nature, frequency and severity of Adverse Events (Part 1 and Part 2)
Adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). Treatment Emergent Adverse Event (TEAE) is defined as any AE starting or worsening at any time from first dosing until last scheduled procedure.
Measured: Part 1: Up to Day 16 / Part 2: Up to Day 29
Number of Participants with Vital Sign Abnormalities and/or Adverse Events (Part 1 and Part 2)
Number of participants with potentially clinically significant vital sign values.
Measured: Part 1: Up to Day 16 / Part 2: Up to Day 29
Number of Participants with Laboratory Value Abnormalities and/or Adverse Events (Part 1 and Part 2)
Number of participants with potentially clinically significant laboratory values.
Measured: Part 1: Up to Day 16 / Part 2: Up to Day 29
Safety assessed by routine 12-Lead Electrocardiogram (ECG) (Part 1 and Part 2)
Any clinically significant adverse changes on the ECG will be reported as an AE.
Measured: Part 1: Up to Day 16 / Part 2: Up to Day 29
Safety assessed by continuous 12-Lead Electrocardiogram (ECG) (Part 1 and Part 2)
Any clinically significant adverse changes on the ECG will be reported as an AE.
Measured: Part 1: Up to Day 2 / Part 2: Up to Day 17
Safety assessed by Real-time cardiac monitoring (telemetry) (Part 1)
Number of participants with potentially clinically significant telemetry abnormalities.
Measured: Part 1: Up to Day 1
Safety assessed by Cardiac troponin T (cTnT) (Part 1 and Part 2)
Number of participants with potentially clinically significant cTnT abnormalities. Cardiac troponin T is a component of the contractile apparatus of myocardial cells and is expressed almost exclusively in the heart.
Measured: Part 1: Up to Day 16 / Part 2: Up to Day 29
Safety assessed by Cardiac troponin I (cTnI) (Part 1 and Part 2)
Number of participants with potentially clinically significant cTnI abnormalities. Cardiac troponin I is a component of the contractile apparatus of myocardial cells and is expressed almost exclusively in the heart.
Measured: Part 1: Up to Day 16 / Part 2: Up to Day 29
Safety assessed by Orthostatic challenge test (OCT) (Part 1 and Part 2)
Number of participants with potentially clinically significant OCT changes will be reported as an AE.
Measured: Part 1: Up to Day 1 / Part 2: Up to Day 14

Secondary outcomes (31)

Part 1: Pharmacokinetics (PK) of ASP7713 in plasma: area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf)
AUCinf will be derived from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to Day 7
Part 1: PK of ASP7713 in plasma: area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
AUClast will be derived from the PK plasma samples collected.
Measured: Up to Day 7
Part 1: PK of ASP7713 in plasma: percentage of AUCinf due to extrapolation from time of the last measurable concentration to time infinity (AUCinf(%extrap))
AUCinf(%extrap) will be derived from the PK plasma samples collected.
Measured: Up to Day 7
Part 1: PK of ASP7713 in plasma: maximum concentration (Cmax)
Cmax will be derived from the PK plasma samples collected.
Measured: Up to Day 7
Part 1: PK of ASP7713 in plasma: apparent total systemic clearance after extravascular dosing (CL/F)
CL/F will be derived from the PK plasma samples collected.
Measured: Up to Day 7
Part 1: PK of ASP7713 in plasma: time prior to the time corresponding to the first measurable (nonzero) concentration (tlag)
tlag will be derived from the PK plasma samples collected.
Measured: Up to Day 7
Part 1: PK of ASP7713 in plasma: time of maximum concentration (tmax)
tmax will be derived from the PK plasma samples collected.
Measured: Up to Day 7
Part 1: PK of ASP7713 in plasma: terminal elimination half-life (t ½)
t ½ will be derived from the PK plasma samples collected.
Measured: Up to Day 7
Part 1: PK of ASP7713 in plasma: apparent volume of distribution during the terminal elimination phase after extravascular dosing (Vz/F)
Vz/F will be derived from the PK plasma samples collected.
Measured: Up to Day 7
Part 1: PK of ASP7713 in urine: cumulative amount of study drug excreted into urine from time of dosing up to the collection time of the last measurable concentration (Aelast)
Aelast will be derived from the PK urine samples collected.
Measured: Up to Day 4
Part 1: PK of ASP7713 in urine: percentage of study drug dose excreted into urine from time of dosing up to the collection time of the last measurable concentration (Aelast%)
Aelast% will be derived from the PK urine samples collected.
Measured: Up to Day 4
Part 1: PK of ASP7713 in urine: cumulative amount of study drug excreted into urine from time of dosing extrapolated to time infinity (Aeinf)
Aeinf will be derived from the PK urine samples collected.
Measured: Up to Day 4
Part 1: PK of ASP7713 in urine: percentage of study drug dose excreted into urine from time of dosing extrapolated to time infinity (Aeinf%)
Aeinf% will be derived from the PK urine samples collected.
Measured: Up to Day 4
Part 1: PK of ASP7713 in urine: renal clearance (CLR)
CLR will be derived from the PK urine samples collected.
Measured: Up to Day 4
Part 2: PK of ASP7713 in plasma: area under the concentration-time curve from the time of dosing to 24 hours postdose (AUC24)
AUC24 will be derived from the PK plasma samples collected.
Measured: Day 1
Part 2: PK of ASP7713 in plasma: area under the concentration-time curve from the time of dosing to 12 hours postdose (AUC12)
AUC12 will be derived from the PK plasma samples collected.
Measured: Days 1 and 14
Part 2: PK of ASP7713 in plasma: area under the concentration-time curve from the time of dosing to 8 hours postdose (AUC8)
AUC8 will be derived from the PK plasma samples collected.
Measured: Days 1 and 14
Part 2: PK of ASP7713 in plasma: Cmax
Cmax will be derived from the PK plasma samples collected.
Measured: Day 1, Day 12 (for twice daily dosing) and Day 14
Part 2: PK of ASP7713 in plasma: tlag
tlag will be derived from the PK plasma samples collected.
Measured: Day 1
Part 2: PK of ASP7713 in plasma: tmax
tmax will be derived from the PK plasma samples collected.
Measured: Day 1, Day 12 (for twice daily dosing) and Day 14
Part 2: PK of ASP7713 in plasma: area under the concentration-time curve from the time of dosing to the start of the next dosing interval (AUCtau)
AUCtau will be derived from the PK plasma samples collected.
Measured: Day 12 (for twice daily dosing) and Day 14
Part 2: PK of ASP7713 in plasma: apparent total systemic clearance after extravascular dosing (CL/F)
CL/F will be derived from the PK plasma samples collected.
Measured: Day 12 (for twice daily dosing) and Day 14
Part 2: PK of ASP7713 in plasma: peak trough ratio (PTR)
PTR will be derived from the PK plasma samples collected.
Measured: Day 12 (for twice daily dosing) and Day 14
Part 2: PK of ASP7713 in plasma: accumulation ratio calculated using the area under the concentration time (Rac(AUC))
Rac(AUC) will be derived from the PK plasma samples collected.
Measured: Day 12 (for twice daily dosing) and Day 14
Part 2: PK of ASP7713 in plasma: t ½
t ½ will be derived from the PK plasma samples collected.
Measured: Day 12 (for twice daily dosing)
Part 2: PK of ASP7713 in plasma: Vz/F
Vz/F will be derived from the PK plasma samples collected.
Measured: Day 12 (for twice daily dosing)
Part 2: PK of ASP7713 in urine: cumulative amount of study drug excreted into urine from the time of dosing to the start of the next dosing interval (Aetau)
Aetau will be derived from the PK urine samples collected.
Measured: Day 14
Part 2: PK of ASP7713 in urine: percentage of study drug dose excreted into urine from the time of dosing to the start of the next dosing interval (Aetau%)
Aetau% will be derived from the PK urine samples collected.
Measured: Day 14
Part 2: PK of ASP7713 in urine: CLR
CLR will be derived from the PK urine samples collected.
Measured: Day 14
Part 2: PK of ASP7713 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough)
Ctrough will be derived from the PK plasma samples collected.
Measured: Days 2, 4, 6, 8, 10, 12 (for twice or 3 times daily dosing) , 14 and 15
Part 2: PK of ASP7713 in urine: concentration immediately prior to dosing at multiple dosing (Ctrough)
Ctrough will be derived from the PK urine samples collected.
Measured: Days 2, 4, 6, 8, 10, 12 (for twice or 3 times daily dosing), 14 and 15

Timeline

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

23 May 201725 Aug 2017

First posted11 Apr 2017
Study start23 May 2017
Primary completion25 Aug 2017
Study completion25 Aug 2017

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: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03108755
Sponsor's protocol ID: 7713-CL-0001
Other IDs: 2016-004845-10, 2016
Status last verified: Mar 2018
First submitted: 6 Apr 2017
Last updated: 7 Mar 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Combined Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP7713 in Healthy Non-Japanese Adult and Elderly Subjects and Healthy Japanese Adult Subjects
ClinicalTrials.gov ID: NCT03108755
Acronym / sponsor ID: 7713-CL-0001
Conditions: Healthy Volunteers
Keywords: ASP7713
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
Study start: 23 May 2017 (actual)
Primary completion: 25 Aug 2017 (actual)
Study completion: 25 Aug 2017 (actual)
First posted: 11 Apr 2017 (actual)
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.

This is a combined Single and Multiple Ascending Oral Dose Study. Part 1 is a Single Ascending Dose (SAD) and Part 2 is Multiple Ascending Dose (MAD).

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
ASP7713 Single Ascending Dose	Experimental	Drug: ASP7713Successive cohorts of 8 non-Japanese participants (6 ASP7713/ 2 Placebo / 1-7 cohorts) will be started on a fixed single dose of ASP7713 or matching Placebo. The first two participants will receive either ASP7713 or matching placebo. If no safety issues are observed in the first 24 hours in the first two participants, then the remaining six participants will be dosed. Safety, tolerability and available Pharmacokinetic data from proceeding cohorts will be assessed for dose escalation.
Placebo Single Ascending Dose	Placebo comparator	Drug: PlaceboSuccessive cohorts of 8 non-Japanese participants (6 ASP7713/ 2 Placebo / 1-7 cohorts) will each be started on a single fixed dose of ASP7713 or matching Placebo. The first two participants will receive either ASP7713 or matching placebo. If no safety issues are observed in the first 24 hours in the first two participants, then the remaining six participants will be dosed. Safety, tolerability and available Pharmacokinetic data from proceeding cohorts will be assessed for dose escalation.
ASP7713 Multiple Ascending Dose (Adults: 18-55 years)	Experimental	Drug: ASP7713Successive cohorts of 16 participants consisting of 8 non-Japanese and 8 Japanese (12 ASP7713/ 4 Placebo /1-3 cohorts) will each be started on a fixed multiple dose of ASP7713 or matching Placebo twice or three times daily for 14 days. Safety, tolerability and available Pharmacokinetic data from proceeding cohorts will be assessed for dose escalation.
Placebo Multiple Ascending Dose (Adults: 18-55 years)	Placebo comparator	Drug: PlaceboSuccessive cohorts of 16 participants consisting of 8 non-Japanese and 8 Japanese (12 ASP7713/ 4 Placebo /1-3 cohorts) will each be started on a fixed multiple dose of ASP7713 or matching Placebo twice or three times daily for 14 days. Safety, tolerability and available Pharmacokinetic data from proceeding cohorts will be assessed for dose escalation.
ASP7713 Multiple Ascending Dose (Elderly: 65 years or older)	Experimental	Drug: ASP7713Dosing of the non-Japanese elderly cohort will commence after having established the safety and tolerability of corresponding dose in adults male and female participants.
Placebo Multiple Ascending Dose (Elderly: 65 years or older)	Placebo comparator	Drug: PlaceboDosing of the non-Japanese elderly cohort will commence after having established the safety and tolerability of corresponding dose in adults male and female participants.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Subject is a healthy non-Japanese adult male or female subject between 18 to 55 years of age, inclusive, at screening or subject is a healthy non-Japanese elderly male or female subject, ≥ 65 years of age and has a body mass index (BMI) range of 18.5 to 30.0 kg/m2, inclusive and weighs at least 50 kg at screening and day -1 OR Subject is a healthy Japanese adult male or female subject between 20 to 55 years of age, inclusive, at screening and has a BMI range of 18.0 to 28.0 kg/m2, inclusive and weighs at least 45 kg at screening and day -1.
In case of Japanese subject: subject is from Japanese origin. Both parents and all 4 grandparents should be Japanese. The subject should have been born in Japan and should not have lived outside of Japan for more than 10 years.
Female subject must either:
Female subject must agree not to breastfeed starting at screening and throughout the study period and for 28 days after the final study drug administration.
Female subject must not donate ova starting at screening and throughout the study period and for 28 days after the final study drug administration.

Key exclusion criteria (27 listed)

Subject has received investigational therapy within 28 days (or 5 half-lives, whichever is longer) prior to screening.
Subject has any condition which makes the subject unsuitable for study participation.
Female subject who has been pregnant within 6 months prior to screening assessment or breast feeding within 3 months prior to screening.
Subject has a known or suspected hypersensitivity to ASP7713, or any components of the formulation used.
Subject has had previous exposure with ASP7713.

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
ASP7713oral	Drug	ASP7713 Multiple Ascending Dose (Adults: 18-55 years), ASP7713 Multiple Ascending Dose (Elderly: 65 years or older), ASP7713 Single Ascending Dose
Placebooral	Drug	Placebo Multiple Ascending Dose (Adults: 18-55 years), Placebo Multiple Ascending Dose (Elderly: 65 years or older), Placebo Single Ascending Dose

Primary outcome

Safety as assessed by nature, frequency and severity of Adverse Events (Part 1 and Part 2)
Time frame: Part 1: Up to Day 16 / Part 2: Up to Day 29
Adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). Treatment Emergent Adverse Event (TEAE) is defined as any AE starting or worsening at any time from first dosing until last scheduled procedure.
Number of Participants with Vital Sign Abnormalities and/or Adverse Events (Part 1 and Part 2)
Time frame: Part 1: Up to Day 16 / Part 2: Up to Day 29
Number of participants with potentially clinically significant vital sign values.
Number of Participants with Laboratory Value Abnormalities and/or Adverse Events (Part 1 and Part 2)
Time frame: Part 1: Up to Day 16 / Part 2: Up to Day 29
Number of participants with potentially clinically significant laboratory values.
Safety assessed by routine 12-Lead Electrocardiogram (ECG) (Part 1 and Part 2)
Time frame: Part 1: Up to Day 16 / Part 2: Up to Day 29
Any clinically significant adverse changes on the ECG will be reported as an AE.
Safety assessed by continuous 12-Lead Electrocardiogram (ECG) (Part 1 and Part 2)
Time frame: Part 1: Up to Day 2 / Part 2: Up to Day 17
Any clinically significant adverse changes on the ECG will be reported as an AE.
Safety assessed by Real-time cardiac monitoring (telemetry) (Part 1)
Time frame: Part 1: Up to Day 1
Number of participants with potentially clinically significant telemetry abnormalities.
Safety assessed by Cardiac troponin T (cTnT) (Part 1 and Part 2)
Time frame: Part 1: Up to Day 16 / Part 2: Up to Day 29
Number of participants with potentially clinically significant cTnT abnormalities. Cardiac troponin T is a component of the contractile apparatus of myocardial cells and is expressed almost exclusively in the heart.
Safety assessed by Cardiac troponin I (cTnI) (Part 1 and Part 2)
Time frame: Part 1: Up to Day 16 / Part 2: Up to Day 29
Number of participants with potentially clinically significant cTnI abnormalities. Cardiac troponin I is a component of the contractile apparatus of myocardial cells and is expressed almost exclusively in the heart.
Safety assessed by Orthostatic challenge test (OCT) (Part 1 and Part 2)
Time frame: Part 1: Up to Day 1 / Part 2: Up to Day 14
Number of participants with potentially clinically significant OCT changes will be reported as an AE.

31 secondary outcomes

Part 1: Pharmacokinetics (PK) of ASP7713 in plasma: area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf)
Time frame: Up to Day 7
Part 1: PK of ASP7713 in plasma: area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
Time frame: Up to Day 7
Part 1: PK of ASP7713 in plasma: percentage of AUCinf due to extrapolation from time of the last measurable concentration to time infinity (AUCinf(%extrap))
Time frame: Up to Day 7
Part 1: PK of ASP7713 in plasma: maximum concentration (Cmax)
Time frame: Up to Day 7
Part 1: PK of ASP7713 in plasma: apparent total systemic clearance after extravascular dosing (CL/F)
Time frame: Up to Day 7
Part 1: PK of ASP7713 in plasma: time prior to the time corresponding to the first measurable (nonzero) concentration (tlag)
Time frame: Up to Day 7
Part 1: PK of ASP7713 in plasma: time of maximum concentration (tmax)
Time frame: Up to Day 7
Part 1: PK of ASP7713 in plasma: terminal elimination half-life (t ½)
Time frame: Up to Day 7
Part 1: PK of ASP7713 in plasma: apparent volume of distribution during the terminal elimination phase after extravascular dosing (Vz/F)
Time frame: Up to Day 7
Part 1: PK of ASP7713 in urine: cumulative amount of study drug excreted into urine from time of dosing up to the collection time of the last measurable concentration (Aelast)
Time frame: Up to Day 4
Part 1: PK of ASP7713 in urine: percentage of study drug dose excreted into urine from time of dosing up to the collection time of the last measurable concentration (Aelast%)
Time frame: Up to Day 4
Part 1: PK of ASP7713 in urine: cumulative amount of study drug excreted into urine from time of dosing extrapolated to time infinity (Aeinf)
Time frame: Up to Day 4
Part 1: PK of ASP7713 in urine: percentage of study drug dose excreted into urine from time of dosing extrapolated to time infinity (Aeinf%)
Time frame: Up to Day 4
Part 1: PK of ASP7713 in urine: renal clearance (CLR)
Time frame: Up to Day 4
Part 2: PK of ASP7713 in plasma: area under the concentration-time curve from the time of dosing to 24 hours postdose (AUC24)
Time frame: Day 1
Part 2: PK of ASP7713 in plasma: area under the concentration-time curve from the time of dosing to 12 hours postdose (AUC12)
Time frame: Days 1 and 14
Part 2: PK of ASP7713 in plasma: area under the concentration-time curve from the time of dosing to 8 hours postdose (AUC8)
Time frame: Days 1 and 14
Part 2: PK of ASP7713 in plasma: Cmax
Time frame: Day 1, Day 12 (for twice daily dosing) and Day 14
Part 2: PK of ASP7713 in plasma: tlag
Time frame: Day 1
Part 2: PK of ASP7713 in plasma: tmax
Time frame: Day 1, Day 12 (for twice daily dosing) and Day 14
Part 2: PK of ASP7713 in plasma: area under the concentration-time curve from the time of dosing to the start of the next dosing interval (AUCtau)
Time frame: Day 12 (for twice daily dosing) and Day 14
Part 2: PK of ASP7713 in plasma: apparent total systemic clearance after extravascular dosing (CL/F)
Time frame: Day 12 (for twice daily dosing) and Day 14
Part 2: PK of ASP7713 in plasma: peak trough ratio (PTR)
Time frame: Day 12 (for twice daily dosing) and Day 14
Part 2: PK of ASP7713 in plasma: accumulation ratio calculated using the area under the concentration time (Rac(AUC))
Time frame: Day 12 (for twice daily dosing) and Day 14
Part 2: PK of ASP7713 in plasma: t ½
Time frame: Day 12 (for twice daily dosing)
Part 2: PK of ASP7713 in plasma: Vz/F
Time frame: Day 12 (for twice daily dosing)
Part 2: PK of ASP7713 in urine: cumulative amount of study drug excreted into urine from the time of dosing to the start of the next dosing interval (Aetau)
Time frame: Day 14
Part 2: PK of ASP7713 in urine: percentage of study drug dose excreted into urine from the time of dosing to the start of the next dosing interval (Aetau%)
Time frame: Day 14
Part 2: PK of ASP7713 in urine: CLR
Time frame: Day 14
Part 2: PK of ASP7713 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough)
Time frame: Days 2, 4, 6, 8, 10, 12 (for twice or 3 times daily dosing) , 14 and 15
Part 2: PK of ASP7713 in urine: concentration immediately prior to dosing at multiple dosing (Ctrough)
Time frame: Days 2, 4, 6, 8, 10, 12 (for twice or 3 times daily dosing), 14 and 15

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 7 Mar 2018.
Individual participant dataSharing planned: Undecided

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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 ASP7713 in people with Healthy Volunteers, 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 11 inclusion and 27 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 7 Mar 2018. 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 nature, frequency and severity of Adverse Events (Part 1 and Part 2) (time frame: Part 1: Up to Day 16 / Part 2: Up to Day 29). 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 NCT03108755.

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 7 Mar 2018.