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Healthy VolunteersPhase 1NCT02285465

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP3700 in Healthy Subjects

A Phase 1 study testing ASP3700 in people with Healthy Volunteers and Pharmacokinetics of ASP3700, run by Astellas Pharma Europe B.V..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ascending multiple oral doses of ASP3700 in healthy subjects. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
What is being tested?
ASP3700
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Nov 2014to Nov 2014
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 skin type I, II or III (Fitzpatrick classification).
  • Subject has a body mass index (BMI) of 18.5 to 30.0 kg/m2, inclusive. The subject weighs at least 50 kg at screening.

Who cannot join

  • 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 ASP3700 or any components of the formulation used.
  • Subject does not respond to the capsaicin challenge at screening or day -1. A nonresponder is defined by a dermal blood flow (DBF) of ≤ 100% increase from baseline (normal skin) compared to DBF 30 minutes after application of 0.4 mL (approximately 300 µg) of capsaicin cream (Axsain®, 0.075% capsaicin w/w).
  • Subject does not respond to the histamine challenge at screening or day -1. A nonresponder is defined by an insufficient wheal (mean diameter < 0.5 cm) and/or flare (mean diameter < 2 cm) reaction (visually assessed and measured by trained staff member) after 10 minutes of the histamine intradermal injection.
  • Subject has a history of suicide attempt or suicidal behavior. Any suicidal ideation within the last 3 months (a level of 4 or 5 for any 1 item on the scale), or who are at significant risk to commit suicide, as judged by the investigator using the C-SSRS at screening and on admission to the clinical unit on day -1.
  • Subject has any of the liver function tests (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 on day -1.
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  • Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Subject has a history of clinically significant reaction to cannabis or synthetic cannabinoids as judged by the investigator.
  • 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, as judged by the investigator.
  • 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.
  • Subject has any clinically significant abnormality following the investigator's review of the physical examination, electrocardiogram (ECG) and protocol defined clinical laboratory tests at screening or day -1.
  • Subject has a mean pulse < 40 or > 90 bpm; mean systolic blood pressure (SBP) > 140 mmHg; mean diastolic blood pressure (DBP) > 90 mmHg (vital sign measurements taken in triplicate after subject has been resting in supine position for 5 minutes; pulse will be measured automatically) on day -1. If the mean pulse, mean SBP or mean DBP is out of the range as specified above, 1 additional triplicate measurement may be taken.
  • Subject has a mean QTc(F) interval of > 430 ms (for males) and > 450 ms (for females) at day -1. If the mean QTc(F) exceeds the limits above, 1 additional triplicate ECG can be taken.
  • Subject uses any prescribed or nonprescribed drugs (including antihistamines, 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 on day -1.
  • Subject has a history of drinking > 21 units of alcohol per week for male subjects or > 14 units of alcohol 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 on day -1.
  • Subject has used any drugs of abuse within 3 months prior to admission to the clinical unit on day -1.
  • Subject has used any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to admission to the clinical unit on day -1.
  • Subject has consumed grapefruit, grapefruit-containing products, Seville orange-containing products, caffeine, xanthine, quinidine or theobromine containing products within 72 hours prior to admission to the clinical unit on day -1.
  • 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 on day -1.
  • Subject has a positive serology test for hepatitis B surface antigen (HBsAg), hepatitis A virus antibodies (immunoglobulin M) (antiHAV [IgM]), hepatitis C virus antibodies (antiHCV), 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 3 months or 5 half-lives, whichever is longer, prior to screening.
  • Subject has a skin disease, acute or chronic (e.g., atopic dermatitis) or any active dermatological conditions, local pigmentary disorders, or body art (e.g., tattoos) that might interfere with the clinical study assessments.
  • Subject has any condition which, in the investigator's opinion, makes the subject unsuitable for clinical study participation.
  • Subject is an employee of the Astellas Group or Contract Research Organization (CRO) involved in the clinical study.

About this study

Official title: A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Multiple Oral Doses of ASP3700 in Healthy Subjects

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ascending multiple oral doses of ASP3700 in healthy subjects.

Read the detailed description

Subjects will be confined in the clinic for 18 days.

Being tested
ASP3700, Placebo
Keywords
Healthy volunteers, Pharmacokinetics, Pharmacodynamics, ASP3700

What participants receive

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

  • ASP3700Drug

    Oral

  • PlaceboDrug

    Oral

Study groups in NCT02285465
Study groupRoleWhat they receive
ASP3700 multiple ascending dose cohortExperimentalNot described
Receives: Drug: ASP3700
Placebo cohortPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Safety as assessed by adverse events

    Measured: up to end of study visit (up to 26 days)

  2. Safety as assessed by vital signs

    Measured: up to end of study visit (up to 26 days)

  3. Safety as assessed by orthostatic evaluation

    Measured: Days 1 and 14

  4. Safety as assessed by laboratory tests

    Laboratory tests include hematology, biochemistry and urinalysis.

    Measured: up to end of study visit (up to 26 days)

Secondary outcomes (6)

  1. Safety profile: Routine 12-lead ECG, C-SSRS, ARCI-49, Bond and Lader VAS, continuous cardiac monitoring (12-lead Holter ECG), exploratory sex hormone-related and renal biomarkers

    Electrocardiogram (ECG); Columbia-Suicide Severity Rating Scale (C-SSRS); Addiction Research Center Inventory(ARCI)-49 (49-item); Visual Analog Scale (VAS).

    Measured: up to end of study visit (up to 26 days)

  2. Pharmacokinetics profile of ASP3700 (plasma): Cmax, tmax, tlag

    Maximum concentration (Cmax); time of maximum concentration (tmax); time prior to the time corresponding to the first measurable (nonzero) concentration (tlag)

    Measured: Cmax, tmax = Days 1 and 14; tlag = Day 1

  3. Pharmacokinetics profile of ASP3700 (plasma): AUCtau, CL/F, λz, MRT, t1/2, Vz/F, Rac (AUC), Rac (Cmax), PTR

    Area under the concentration-time curve from the time of dosing to the start of the next dosing interval (AUCtau); apparent oral clearance (CL/F); terminal elimination rate constant (λz); mean residence time (MRT); terminal elimination half-life (t1/2); apparent volume of distribution during terminal elimination phase after extravascular dosing (Vz/F); accumulation ratio based on AUE (Rac[AUC]); accumulation ratio based on Cmax (Rac[Cmax]); peak-trough ration (PTR)

    Measured: Day 14

  4. Pharmacokinetics parameter of ASP3700 (plasma): Ctrough

    Concentration immediately prior to dosing at multiple dosing (Ctrough)

    Measured: Days 4, 6, 8, 10, 14 and 15

  5. Pharmacokinetics profile of ASP3700 (urine): Ae24, Ae24%, Aetau, Aetau%

    Cumulative amount of drug excreted in the urine from Time Zero to 24 hours (Ae24); percent fraction of administered drug excreted unchanged in the urine from time zero to 24 hours (Ae24%); cumulative amount of drug excreted in the urine over the dosing interval at steady-state (Aetau); percent fraction of administered drug excreted unchanged in the urine over the dosing interval at steady-state (Aetau%)

    Measured: Ae24, Ae24% = Day 1; Aetau, Aetau% = Day14

  6. Pharmacokinetics parameter of ASP3700 (urine): CLR

    Renal clearance (CLR)

    Measured: Days 1 and 14

Timeline

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

  1. First posted7 Nov 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionNov 2014
  4. Study completionNov 2014

Why it stopped: Study terminated due to sponsor decision

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02285465
Sponsor's protocol ID
3700-CL-0002
Other IDs
2014-003226-41, 2014
Status last verified
Jan 2015
First submitted
5 Nov 2014
Last updated
12 Jan 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASP3700 in people with Healthy Volunteers and Pharmacokinetics of ASP3700, run by Astellas Pharma Europe B.V..

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 2 inclusion and 25 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: withdrawn, as of the sponsor's last update on 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

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 withdrawn before enrolling participants, so there are no results.

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 (up to 26 days)). The study lists 4 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 NCT02285465.

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 12 Jan 2015.

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