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Healthy VolunteersPhase 1NCT04742517

A Study of MA-0217 (ASP1128) in Healthy Adult Subjects and Healthy Elderly Subjects

A Phase 1 study testing ASP1128 in people with Healthy Volunteers, run by Astellas Pharma Europe B.V. at 1 site in United States.

Completed

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

Official record
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Trial summary

The primary purpose of this study is to evaluate the safety and tolerability of single ascending intravenous doses of ASP1128 in healthy adult male and female subjects and multiple ascending intravenous doses of ASP1128 in healthy adult male and female subjects and healthy elderly male and female subjects. 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?
ASP1128
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
102 participants
Where
1 siteUnited States
Study dates
20 Nov 2017to 7 Sep 2018
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

  • For adult subjects (cohorts 1.1 to 1.8 and cohorts 2.1 to 2.5):
  • Subject is a healthy adult male or female subject 18 to 55 years of age, inclusive at screening.
  • Subject has a body mass index (BMI) range of 18.5 to 32.0 kg/m^2, inclusive and weighs at least 50 kg at screening.
  • For elderly subjects (cohort 2.6):
  • Subject is a healthy elderly male or female subject ≥ 65 years of age at screening.
  • Subject has a BMI range of 18.5 to 32.0 kg/m^2, inclusive and weighs at least 50 kg at screening.
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  • Subject is considered an adult according to local regulation at the time of signing informed consent.
  • Female subject must either be of nonchildbearing potential:
  • Postmenopausal (defined as at least 1 year without any menses for which there is no other obvious pathological or physiological cause) prior to screening, or
  • Documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy or 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
  • Have a negative blood pregnancy test at screening and a negative urine pregnancy test on day -1
  • If heterosexually active, agree to consistently use 1 form of highly effective birth control 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.
  • A sexually active male subject with female partner(s) who is(are) of childbearing potential is eligible for the study if:
  • Agree to use a male condom starting at screening and continue throughout study treatment and for 28 days after the final study drug administration.
  • If the male subject has not had a vasectomy or is not sterile, their female partner(s) is(are) utilizing 1 form of highly effective birth control starting at screening and continue throughout study treatment and for 28 days after the male subject receives their 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 condom for the duration of the pregnancy or time partner(s) is(are) 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 drug 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 or breastfeeding within 3 months prior to screening.
  • Subject has a known or suspected hypersensitivity to ASP1128 or any components of the formulation used.
  • Subject has had previous exposure with ASP1128.
  • Subject has unsuitable or difficult venous access to support the intravenous infusion(s) and/or required blood draws.
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  • Subject has any of the liver function tests (LFTs; aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], gamma-glutamyl transferase and total bilirubin [TBL]) above the upper limit of normal (ULN) at screening or on day -1. In such a case, the assessment may be repeated once.
  • Subject has total creatine kinase (CK) > 1.5 × ULN or cardiac troponin I above the ULN at day -1.
  • 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 physical examination, electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or on day -1.
  • Subject has a mean pulse < 45 or > 90 bpm; mean systolic blood pressure (SBP) > 140 mmHg; mean diastolic blood pressure (DBP) > 90 mmHg (measurements taken in triplicate after subject has been resting in the supine position for at least 5 minutes; pulse will be measured automatically) at screening or on day -1. For elderly subjects the following criteria apply: SBP > 160 mmHg, DBP > 100 mmHg. If the mean blood pressure exceeds the limits above, 1 additional triplicate can be taken.
  • Subject has a mean QT interval using Fridericia's correction formula (QTcF) interval of > 430 msec (for males) and > 450 msec (for females) at screening or on day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG can be taken.
  • 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 acetaminophen (up to 2 g/day), hormonal contraceptives and hormone replacement therapy.
  • Subject has used any peroxisome proliferator-activated receptor (PPAR) ligands such as fibrates and thiazolidinediones, including self-medication obtained via the internet, in the 4 weeks prior to study drug administration.
  • 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 consuming > 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor) or the subject tests positive for alcohol or drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) at screening or on 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 used any inducer of metabolism (e.g., barbiturates and rifampin) in the 3 months prior to day -1.
  • Subject has had significant blood loss, donated ≥ 1 unit (450 mL) of blood 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 (HBsAg), hepatitis B core (HBc) antibodies, hepatitis A virus (HAV) antibodies (immunoglobulin M [IgM]), hepatitis C virus (HCV) antibodies or antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 at screening.
  • Subject is an employee of Astellas, Mitobridge or designated contract research organization (CRO).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Parexel Early Phase Clinical Unit - Los Angeles

    Glendale, California, 91206

Other trials in United States

About this study

Official title: A Phase 1 Combined Single and Multiple Ascending Intravenous Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MA-0217 in Healthy Adult Subjects and Healthy Elderly Subjects

The primary purpose of this study is to evaluate the safety and tolerability of single ascending intravenous doses of ASP1128 in healthy adult male and female subjects and multiple ascending intravenous doses of ASP1128 in healthy adult male and female subjects and healthy elderly male and female subjects.

This study will also evaluate the pharmacokinetics and the effect on the QT interval using Fridericia's correction formula (QTcF) in these subjects.

Read the detailed description

After a screening period of up to 28 days prior to study drug administration, eligible participants will be residential for a single period of 5 days/4 nights in Part 1: single ascending dose, and 11 days/10 nights in Part 2 multiple ascending dose.

Part 1 is composed of 6 parallel cohorts (cohorts 1.1 to 1.6) and up to 2 optional cohorts (cohorts 1.7 and 1.8) of 8 healthy adult male and female subjects in each cohort. If the data from cohorts 1.1 to 1.6 are not sufficient to characterize safety, tolerability and pharmacokinetics, up to 2 optional cohorts (cohorts 1.7 and 1.8) may be added.

Part 2 is composed of 4 parallel cohorts (cohorts 2.1 to 2.4) and 1 optional cohort (cohort 2.5) of 12 healthy adult male and female subjects in each cohort and 1 cohort (cohort 2.6) of 12 healthy elderly male and female subjects. Dosing of the elderly cohort (cohort 2.6) will commence after having established the safety and tolerability of the corresponding dose tested in cohorts 2.1 to 2.5. If the data from cohorts 2.1 to 2.4 are not sufficient to characterize safety, tolerability and pharmacokinetics, 1 optional cohort (cohort 2.5) may be added.

Being tested
ASP1128, Placebo
Keywords
MA-0217, Healthy Volunteers, Pharmacokinetics, ASP1128

What participants receive

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

  • ASP1128Drug

    Also called MA-0217

    Intravenous

  • PlaceboDrug

    Intravenous

Study groups in NCT04742517
Study groupRoleWhat they receive
Single ascending dose of ASP1128ExperimentalParticipants (6 for each cohort) will receive a single dose of ASP1128.
Receives: Drug: ASP1128
Single ascending dose of PlaceboPlacebo comparatorParticipants (2 for each cohort) will receive a single dose of matching Placebo.
Receives: Drug: Placebo
Multiple ascending dose of ASP1128ExperimentalParticipants (9 for each cohort) will receive daily doses of ASP1128 for 7 consecutive days.
Receives: Drug: ASP1128
Multiple ascending dose of PlaceboPlacebo comparatorParticipants (3 for each cohort) will receive matching Placebo for 7 consecutive days.
Receives: Drug: Placebo

What is being measured

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

  1. Number of participants with Adverse Events (AEs) in Part 1

    An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.

    In order to identify any events that may be associated with study procedures and could lead to a change in the conduct of the study, AEs will be collected even if the subject has not received study drug treatment.

    Measured: Up to Day 16

  2. Number of participants with laboratory value abnormalities and/or AEs in Part 1

    Number of participants with potentially clinically significant laboratory values.

    Measured: Up to Day 16

  3. Number of participants with vital sign abnormalities and/or AEs in Part 1

    Number of participants with potentially clinically significant vital sign values.

    Measured: Up to Day 16

  4. Number of participants with electrocardiogram (ECG) abnormalities and/or AEs in Part 1

    Number of participants with potentially clinically significant 12-ECG values.

    Measured: Up to Day 16

  5. Number of participants with real-time cardiac monitoring (cardiac telemetry) abnormalities and/or AEs in Part 1

    Number of participants with potentially clinically significant cardiac telemetry values.

    Measured: On Day 1

  6. Number of participants with AEs in Part 2

    An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.

    In order to identify any events that may be associated with study procedures and could lead to a change in the conduct of the study, AEs will be collected even if the subject has not received study drug treatment.

    Measured: Up to Day 19

  7. Number of participants with laboratory value abnormalities and/or AEs in Part 2

    Number of participants with potentially clinically significant laboratory values.

    Measured: Up to Day 19

  8. Number of participants with vital sign abnormalities and /or AEs in Part 2

    Number of participants with potentially clinically significant vital sign values.

    Measured: Up to Day 19

  9. Number of participants with ECG abnormalities and/or AEs in Part 2

    Number of participants with potentially clinically significant 12-ECG values.

    Measured: Up to Day 19

Secondary outcomes (29)

  1. Part 1: Pharmacokinetics (PK) of ASP1128 in plasma: Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)

    AUCinf will be recorded from the PK plasma samples collected.

    Measured: Up to 72 hours post-dose on Day 1

  2. Part 1: PK of ASP1128 in plasma: AUC from the time of dosing to the last measurable concentration (AUClast)

    AUClast will be recorded from the PK plasma samples collected.

    Measured: Up to 72 hours post-dose on Day 1

  3. Part 1: PK of ASP1128 in plasma: percentage of AUCinf due to extrapolation from time of the last measurable concentration to time infinity (AUCinf(%extrap))

    AUCinf(%extrap) will be recorded from the PK plasma samples collected.

    Measured: Up to 72 hours post-dose on Day 1

  4. Part 1: PK of ASP1128 in plasma: maximum concentration (Cmax)

    Cmax will be recorded from the PK plasma samples collected.

    Measured: Up to 72 hours post-dose on Day 1

  5. Part 1: PK of ASP1128 in plasma: total systemic clearance after intravenous dosing (CL)

    CL will be recorded from the PK plasma samples collected.

    Measured: Up to 72 hours post-dose on Day 1

  6. Part 1: PK of ASP1128 in plasma: time of maximum concentration (tmax)

    Tmax will be recorded from the PK plasma samples collected.

    Measured: Up to 72 hours post-dose on Day 1

  7. Part 1: PK of ASP1128 in plasma: terminal elimination half-life (t1/2)

    T1/2 will be recorded from the PK plasma samples collected.

    Measured: Up to 72 hours post-dose on Day 1

  8. Part 1: PK of ASP1128 in plasma: volume of distribution during terminal elimination phase after intravenous dosing (Vz)

    Vz will be recorded from the PK plasma samples collected.

    Measured: Up to 72 hours post-dose on Day 1

  9. Part 1: PK of ASP1128 in plasma: volume of distribution at steady state determined after intravenous dosing (Vss)

    Vss will be recorded from the PK plasma samples collected.

    Measured: Up to 72 hours post-dose on Day 1

  10. Part 1: PK of ASP1128 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 recorded from the PK urine samples collected.

    Measured: Up to 72 hours post-dose on Day 1

  11. Part 1: PK of ASP1128 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 recorded from the PK urine samples collected.

    Measured: Up to 72 hours post-dose on Day 1

  12. Part 1: PK of ASP1128 in urine: cumulative amount of study drug excreted into urine from time of dosing extrapolated to time infinity (Aeinf)

    Aeinf will be recorded from the PK urine samples collected.

    Measured: Up to 72 hours post-dose on Day 1

  13. Part 1: PK of ASP1128 in urine: percentage of study drug dose excreted into urine from time of dosing extrapolated to time infinity (Aeinf(%))

    Aeinf(%) will be recorded from the PK urine samples collected.

    Measured: Up to 72 hours post-dose on Day 1

  14. Part 1: PK of ASP1128 in urine: renal clearance (CLR)

    CLR will be recorded from the PK urine samples collected.

    Measured: Up to 72 hours post-dose on Day 1

  15. Part 2 (first dose): PK of ASP1128 in plasma: AUC from the time of dosing to 24 hours (AUC24)

    AUC24 will be recorded from the PK plasma samples collected. This will be replaced with ACU12 in case of twice daily dosing.

    Measured: Up to 24 hours post-dose on Day 1

  16. Part 2 (first dose and last dose): PK of ASP1128 in plasma: Cmax

    Cmax will be recorded from the PK plasma samples collected.

    Measured: Up to 24 hours post-dose on Day 1 and up to 72 hours post-dose on Day 7

  17. Part 2 (first dose and last dose): PK of ASP1128 in plasma: tmax

    Tmax will be recorded from the PK plasma samples collected.

    Measured: Up to 24 hours post-dose on Day 1 and up to 72 hours post-dose on Day 7

  18. Part 2 (last dose): PK of ASP1128 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 recorded from the PK plasma samples collected

    Measured: Up to 24 hours post-dose on Day 7

  19. Part 2 (first dose): PK of ASP1128 in plasma: AUCinf

    AUCinf will be recorded from the PK plasma samples collected.

    Measured: Up to 24 hours post-dose on Day 1

  20. Part 2 (first and last dose): PK of ASP1128 in plasma: CL

    CL will be recorded from the PK plasma samples collected.

    Measured: Up to 24 hours post-dose on Day 1 and up to 72 hours post-dose on Day 7

  21. Part 2 (last dose): PK of ASP1128 in plasma: peak trough ratio (PTR)

    PTR will be recorded from the PK plasma samples collected.

    Measured: Up to 72 hours post-dose on Day 7

  22. Part 2 (last dose): PK of ASP1128 in plasma: accumulation ratio calculated using AUC (Rac(AUC))

    Rac(AUC) will be recorded from the PK plasma samples collected

    Measured: Up to 24 hours post-dose on Day 1 and up to 24 hours post-dose on Day 7

  23. Part 2 (first and last dose): PK of ASP1128 in plasma: t1/2

    T1/2 will be recorded from the PK plasma samples collected.

    Measured: Up to 24 hours post-dose on Day 1 and up to 72 hours post-dose on Day 7

  24. Part 2 (first and last dose): PK of ASP1128 in plasma: Vz

    Vz will be recorded from the PK plasma samples collected.

    Measured: Up to 24 hours post-dose on Day 1 and up to 72 hours post-dose on Day 7

  25. Part 2 (first and last dose): PK of ASP1128 in plasma: Vss

    Vss will be recorded from the PK plasma samples collected.

    Measured: Up to 24 hours post-dose on Day 1 and up to 72 hours post-dose on Day 7

  26. Part 2 (last dose): PK of ASP1128 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 recorded from the PK urine samples collected.

    Measured: Up to 24 hours post-dose on Day 7

  27. Part 2 (last dose): PK of ASP1128 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 recorded from the PK urine samples collected.

    Measured: Up to 24 hours post-dose on Day 7

  28. Part 2 (last dose): PK of ASP1128 in urine: CLR

    CLR will be recorded from the PK urine samples collected.

    Measured: Up to 24 hours post-dose on Day 7

  29. Part 2 (Dose on days 2, 4 and 6): PK of ASP1128 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough)

    Ctrough will be recorded from the PK plasma samples collected.

    Measured: Pre-dose on Day 2, 4 and 6

Timeline

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

  1. First posted8 Feb 2021
  2. Study start20 Nov 2017
  3. Primary completion7 Sep 2018
  4. Study completion7 Sep 2018

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
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04742517
Sponsor's protocol ID
1128-CL-0101
Status last verified
Nov 2024
First submitted
3 Feb 2021
Last updated
18 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • Taniuchi Y, van Till JWO, Wojtkowski T, Toyoshima J, Koibuchi A, Sargent B, Han D. Single- and Multiple-dose Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP1128, a Novel Peroxisome Proliferator-activated Receptor delta Modulator, in Healthy Participants. Clin Pharmacol Drug Dev. 2023 Aug;12(8):810-818. doi: 10.1002/cpdd.1236. Epub 2023 Mar 21.

    PubMed 36942507

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASP1128 in people with Healthy Volunteers, run by Astellas Pharma Europe B.V. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 23 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 18 Nov 2024. 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 States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Adverse Events (AEs) in Part 1 (time frame: Up to Day 16). 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 NCT04742517, which also lists 1 linked publication.

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 18 Nov 2024.

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