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Healthy SubjectsPhase 1NCT02314793

A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2205 in Healthy Young Males and Females and Elderly Females and to Evaluate the Effect of Food on the Pharmacokinetics of a Single Dose of of ASP2205

A Phase 1 study testing ASP2205 in people with Healthy Subjects and Pharmacokinetics of ASP2205, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and tolerability of single ascending oral doses of ASP2205 in healthy young male and female subjects. This study will also evaluate the safety and tolerability of multiple ascending oral doses of ASP2205 in healthy young and elderly female subjects. Read more about this study

Who is it for?
Ages 25 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Subjects, Pharmacokinetics of ASP2205
What is being tested?
ASP2205
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
93 participants
Where
1 siteUnited Kingdom
Study dates
Nov 2014to Oct 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 25 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subject is a healthy young male or female subject aged 25 to 55 years, inclusive, at screening (part 1 and 2) or healthy elderly female subject aged ≥ 65 years, inclusive, at screening (part 2 only).
  • Subject has a body mass index (BMI) range of 18.5 - 30.0 kg/m2, inclusive. The subject weighs at least 50 kg (at screening).
  • Subject agrees not to participate in another interventional study while participating in the present study, defined as signing the informed consent form until completion of the last study visit.

Who cannot join

  • Female subject who has been pregnant within 6 months prior to screening assessment or breastfeeding within 3 months prior to screening.
  • Subject has a known or suspected hypersensitivity to ASP2205 or any components of the formulations used.
  • Subject has any of the liver function tests (LTs; aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase (ALP), gamma glutamyl transferase, total bilirubin [TBL]) above the upper limit of normal (ULN). In such a case, the assessment may be repeated once (admission to the clinical unit).
  • Subject has at screening any clinically significant history of allergic conditions (including drug allergies, asthma, eczema or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies).
  • Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic (including surgical procedures to treat pelvic trauma), 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 admission to the clinical unit.
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  • Subject has a relevant history of attempted suicide or suicidal behavior. Any recent suicidal ideation within the last 6 months or who are at significant risk to commit suicide.
  • Subject has any clinically significant abnormality.
  • Subject has a mean pulse < 40 or > 90 bpm; mean systolic blood pressure (SBP) > 140 mmHg; mean DBP > 90 mmHg (elderly subjects: mean SBP > 160 mmHg; mean DBP > 100 mmHg) (vital signs measurements taken in triplicate after subject has been resting in supine position for 5 minutes; pulse will be measured automatically) prior to the admission to the clinical unit (triplicates taken at screening and on admission to the clinical unit). If the mean blood pressure exceeds the limits above, 1 additional triplicate can be taken.
  • Subject has a mean corrected QT interval using Fridericia's formula (QTcF) > 430 ms (for male subjects) and > 450 ms (for female subjects) at admission to the clinical unit. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG can be taken.
  • Subject uses 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 contraceptives or hormone replacement therapy.
  • Subject has a history of smoking within 6 months prior to admission to the clinical unit.
  • Subject has a history of drinking > 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 admission to the clinical unit.
  • Subject uses grapefruit juice (more than 3 × 200 mL) or products containing grapefruit and/or Seville oranges (more than 3 times) in the week prior to admission to the clinical unit until ESV, as reported by the subject.
  • Subject uses any drugs of abuse within 3 months prior to admission to the clinical unit.
  • Subject regularly uses any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to admission to the clinical unit.
  • Subject had 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 (HBsAg), hepatitis A virus antibodies (immunoglobulin M) (anti-HAV [IgM]), hepatitis C virus antibodies (anti-HCV) or antibodies to human immunodeficiency virus type 1 (HIV-1) and/or type 2 (HIV-2) at screening.
  • Subject has been treated with any investigational drugs within 90 days or 5 terminal half-lives, whichever is longer, prior to drug administration.
  • Subject is unable to communicate, read and understand English, or has any other condition which makes the subject unsuitable for study participation.
  • Subject is an employee of the Astellas Group or Clinical Research Organization involved in the study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Site GB44001

    Harrow, HA1 3UJ

Other trials in United Kingdom

About this study

Official title: A Phase 1 Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2205 in Healthy Young Males and Females and Elderly Females and to Evaluate the Effect of Food on the Pharmacokinetics of a Single Dose of ASP2205

The purpose of this study is to evaluate the safety and tolerability of single ascending oral doses of ASP2205 in healthy young male and female subjects. This study will also evaluate the safety and tolerability of multiple ascending oral doses of ASP2205 in healthy young and elderly female subjects.

Read the detailed description

Part 1 is a single ascending dose investigator-blinded study in healthy young male and female subjects. Six doses of ASP2205 or matching placebo will be given to separate cohorts consisting of 8 subjects each, with 6 subjects receiving ASP2205 and 2 subjects receiving matching placebo. ASP2205 or matching placebo will be given as a single oral dose under fasted conditions.

The effect of a high-calorie high-fat meal (breakfast) on the safety, tolerability and pharmacokinetics of a single oral dose of ASP2205 will be evaluated in a separate cohort of 8 subjects in an open-label manner.

Part 2 is a multiple ascending dose subject- and investigator-blinded study comprising 3 cohorts with each 12 healthy young (aged 25 to 55 years) female subjects and 1 cohort with 12 healthy elderly (aged 65 years or older) female subjects who will receive ASP2205 or matching placebo. Nine subjects in each cohort will be treated with ASP2205 and 3 subjects will be treated with matching placebo (ratio 3:1).

Being tested
ASP2205, Placebo
Keywords
Pharmacokinetics, ASP2205

What participants receive

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

  • ASP2205Drug

    oral

  • PlaceboDrug

    oral

Study groups in NCT02314793
Study groupRoleWhat they receive
Part 1: Single Ascending Dose ASP2205 (Fasting)ExperimentalYoung male and female subjects will receive single doses of ASP2205 in a dose escalation format.
Receives: Drug: ASP2205
Part 1: Single Ascending Dose Placebo (Fasting)Placebo comparatorYoung male and female subjects will receive single doses of matching placebo in a dose escalation format.
Receives: Drug: Placebo
Part 1: Single Ascending Dose ASP2205 (Fed)ExperimentalYoung male and female subjects will receive a single dose of ASP2205
Receives: Drug: ASP2205
Part 2: Multiple Ascending Dose ASP2205, Young femalesExperimentalYoung female subjects will receive multiple dosing of ASP2205 for 14 days: single doses on days 1 and 14 and depending on the dosing regimen (based on emerging data from Part 1) either once or twice daily dosing from days 2 to 13.
Receives: Drug: ASP2205
Part 2: Multiple Ascending Dose Placebo, Young femalesPlacebo comparatorYoung female subjects will receive matching placebo for 14 days: single doses on days 1 and 14 and depending on the dosing regimen (based on emerging data from Part 1) either once or twice daily dosing from days 2 to 13.
Receives: Drug: Placebo
Part 2: Multiple Ascending Dose ASP2205, Elderly femalesExperimentalElderly female subjects will receive multiple dosing of ASP2205 for 14 days: single doses on days 1 and 14 and depending on the dosing regimen (based on emerging data from Part 1) either once or twice daily dosing from days 2 to 13.
Receives: Drug: ASP2205
Part 2: Multiple Ascending Dose Placebo, Elderly femalesPlacebo comparatorElderly female subjects will receive matching placebo for 14 days: single doses on days 1 and 14 and depending on the dosing regimen (based on emerging data from Part 1) either once or twice daily dosing from days 2 to 13.
Receives: Drug: Placebo

What is being measured

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

  1. Part 1 and Part 2: Safety assessed by nature, frequency and severity of adverse events

    Measured: up to 29 days

  2. Part 1 and Part 2: Safety assessed by vital signs

    Vital signs include blood pressure, pulse rate, body temperature

    Measured: up to 29 days

  3. Part 1 and Part 2: Safety assessed by orthostatic challenge test

    Measured: up to 29 days

  4. Part 1 and Part 2: Assessment of clinical laboratory tests

    Clinical laboratory tests include hematology, biochemistry and urinalysis

    Measured: up to 29 days

  5. Part 1 and Part 2: Safety assessed by routine 12 lead electrocardiogram (ECG)

    Measured: up to 29 days

  6. Part 1 and Part 2: Safety assessed by continuous cardiac monitoring (Holter ECG)

    Measured: up to 29 days

  7. Part 1: Safety assessed by real-time cardiac monitoring (ECG telemetry)

    Measured: up to 16 days

Secondary outcomes (28)

  1. Part 1 and Part 2: Safety laboratory test: prolactin

    Measured: up to 29 days

  2. Part 1 and Part 2: Safety laboratory test: cortisol

    Measured: up to 29 days

  3. Part 1 and Part 2: Safety laboratory test: bicarbonate (HCO3)

    Measured: up to 29 days

  4. Part 1 and Part 2: Safety assessed by chemistry profile

    Chemistry profile includes total cholesterol, high-density lipoprotein (HDL) / low-density lipoprotein (LDL), triglycerides

    Measured: up to 29 days

  5. Part 1 and Part 2: Safety laboratory test: fasting blood glucose

    Measured: up to 29 days

  6. Part 1 and Part 2: Safety laboratory test: creatinine urine

    Measured: up to 29 days

  7. Part 1: Central nervous system (CNS) safety monitoring: Bond & Lader visual analogue scale (VAS)

    Measured: up to 4 days

  8. Part 1: CNS safety monitoring: Drug effects questionnaire (DEQ) VAS

    PhenX toolkit version

    Measured: up to 4 days

  9. Part 1: Pharmacokinetics profile of ASP2205 in plasma: AUCinf, AUCinf (% extrapolated), AUClast, AUC24, CL/F, Cmax, terminal elimination rate constant, MRT, tlag, tmax, t1/2, Vz/F

    Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf), percentage of AUCinf due to extrapolation from tlast to time infinity (AUCinf %extrapolated), AUC from the time of dosing to the last measurable concentration (AUClast), AUC from the time of dosing to 24 hours (AUC24), apparent total systemic clearance after single or multiple extravascular dosing (CL/F), maximum concentration (Cmax), mean residence time (MRT), time prior to the time corresponding to the first measurable (nonzero) concentration (tlag), time to maximum concentration (tmax), terminal elimination half-life (t1/2), apparent volume of distribution during the terminal elimination phase after single or multiple extravascular dosing (Vz/F)

    Measured: Day 1

  10. Part 1: Pharmacokinetics profile of ASP2205 in urine: Aeinf, Aeinf%, Aelast, Aelast%, CLR

    Cumulative amount of drug excreted into urine from time of dosing extrapolated to time infinity (Aeinf), percentage of drug dose excreted into urine from time of dosing extrapolated to time infinity (Aeinf%), cumulative amount of drug excreted into urine from time of dosing up to the collection time of the last measurable concentration (Aelast), percentage of drug dose excreted into urine from time of dosing up to the collection time of the last measurable concentration (Aelast%), renal clearance (CLR)

    Measured: Day 1

  11. Part 2: Safety laboratory test: di-docosahexaenoyl-bis(monoacylglycerol) phosphate (di-22:6-BMP) in serum and urine

    Measured: up to 29 days

  12. Part 2: CNS safety monitoring: CogState's neurocognition test battery (short version)

    Measured: up to 14 days

  13. Part 2: CNS safety monitoring: Bond & Lader VAS

    Measured: up to 17 days

  14. Part 2: CNS safety monitoring: DEQ VAS

    PhenX toolkit version

    Measured: Time Frame : up to 13 days

  15. Part 2: CNS safety monitoring: Addiction Research Center Inventory (49-item short form) (ARCI-49)

    Measured: up to 13 days

  16. Part 2: CNS safety monitoring: Physician Withdrawal Checklist

    Measured: up to 29 days

  17. Part 2: CNS safety monitoring: Columbia - Suicide Severity Rate Scale (C-SSRS)

    Measured: up to 29 days

  18. Part 2: Appetite visual analogue scale (AVAS)

    Measured: up to 15 days

  19. Part 2: Nausea VAS

    From the McGill Nausea questionnaire

    Measured: up to 15 days

  20. Part 2: Body weight

    Measured: up to 29 days

  21. Part 2: Total daily urine production (24-hour volume)

    Measured: up to 15 days

  22. Part 2: Total daily urine osmolality (24 hour pooled sample from each void)

    Measured: up to 15 days

  23. Part 2: Total daily fluid intake

    Measured: up to 15 days

  24. Part 2: Pharmacokinetic profile of ASP2205 in plasma: AUC24, Cmax, tlag, tmax

    Measured: Day 1

  25. Part 2: Pharmacokinetic parameter: Ctrough

    Measured: Day 1 immediately prior to dosing (morning Ctrough and, only in case of twice daily dosing, evening C trough): days 2, 4, 6, 8, 10, 12

  26. Part 2: Pharmacokinetic profile of ASP2205 in plasma: AUCtau, Cmax, tmax

    Measured: Days 12, 13 (in case of twice daily dosing)

  27. Part 2: Pharmacokinetic profile of ASP2205 in plasma: AUCtau, CL/F, Cmax, terminal elimination rate constant, MRT, peak trough ratio (PTR), accumulation ratio calculated using the area under the concentration -time curve [Rac(AUC)], tmax, t1/2, VzF

    Measured: Day 14

  28. Part 2: Pharmacokinetic profile of ASP2205 in urine: Aetau, Aetau%, CLR

    Measured: Day 14

Timeline

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

  1. First posted11 Dec 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionOct 2015
  4. Study completionOct 2015

Why it stopped: The study has been terminated because of operational reasons.

Resources

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
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02314793
Sponsor's protocol ID
2205-CL-0001
Other IDs
2014-003059-71, 2014
Status last verified
Jun 2016
First submitted
8 Dec 2014
Last updated
21 Jun 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASP2205 in people with Healthy Subjects and Pharmacokinetics of ASP2205, 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 3 inclusion and 21 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: stopped early, as of the sponsor's last update on 21 Jun 2016. 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 was stopped early (reason given: The study has been terminated because of operational reasons.). Results are not available in the source record.

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?

Part 1 and Part 2: Safety assessed by nature, frequency and severity of adverse events (time frame: up to 29 days). The study lists 7 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 NCT02314793.

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 21 Jun 2016.

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