Healthy SubjectsPhase 1NCT03698305
A Study in Healthy Adult Volunteers to Assess the Safety and Pharmacokinetics of an Investigational Imaging Product
A Phase 1 study testing ASP5354 in people with Healthy Subjects, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial summary
The objective of this study is to assess the safety and tolerability of ASP5354 administered intravenously as a single dose to healthy subjects. This study will also assess the single dose pharmacokinetics of ASP5354 in plasma and urine. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- ASP5354
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2018to 20 May 2019
- 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
- A female subject is eligible to participate if she is not pregnant and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP). OR
- A WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 30 days after the final investigational product (IP) administration.
- Female subject must agree not to breastfeed starting at screening, throughout the study period and for 30 days after the final IP administration.
- Female subject must not donate ova starting at screening, throughout the study period and for 30 days after the final IP administration.
- Male subject with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 30 days after the final IP administration.
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- Male subject must not donate sperm during the treatment period and for at least 30 days after the final IP administration.
- Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom with spermicide for the duration of the pregnancy or time the partner is breastfeeding throughout the study period and for 30 days after the final IP administration.
- Subject agrees not to participate in another interventional study while participating in the present study.
- Subject has a body mass index range of 18.5 to 32.0 kg/m2, inclusive, and weighs > 50 kg (for males) or > 40 kg (for females) at screening.
Who cannot join
- Subject has signs of urinary tract infection, abnormalities or disease or has had operational interventions on the urinary tract.
- Subject has received any IP within 28 days or 5 half-lives (if known), whichever is longer, prior to screening.
- 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 ASP5354 or any components of the formulation used.
- Subject has had previous exposure to ASP5354.
- Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, gamma glutamyl transferase and total bilirubin [TBL]) > upper limit of normal (ULN) at 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) prior to IP 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 2 weeks 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 day 1.
- Subject has a mean pulse < 45 bpm or > 90 bpm, mean systolic blood pressure > 140 mmHg or mean diastolic blood pressure > 90 mmHg at day -1.
- Subject has a mean corrected QT interval using Fridericia's formula (QTcF) > 430 msec (for males) and > 450 msec (for females) at day 1 (as determined by the ECG machine). If the mean QTcF exceeds the limits above, 1 additional triplicate (3 measurements) ECG can be taken.
- Subject has used any prescribed or nonprescribed drugs (including vitamins, oral contraceptives, hormone replacement therapy or natural and herbal remedies [e.g., St. John's Wort]) in the 2 weeks prior to IP administration, except for occasional use of acetaminophen (up to 2 g/day) or topical dermatological products, including corticosteroid products.
- Subject has smoked or has used tobacco-containing products or nicotine or nicotine containing products in the past 6 months prior to screening or the subject tests positive for cotinine at screening or day -1.
- Subject has a history of consuming more than 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 the past 2 years prior to screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor).
- Subject has used any drugs of abuse (including but not limited to amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) within 3 months prior to day -1 or the subject tests positive for alcohol or drugs of abuse (including but not limited to amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) at screening or 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) or more 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, hepatitis B core antibody, hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies or human immunodeficiency virus p24 antigen at screening.
- Subject has any of the renal function tests (blood urea nitrogen and creatinine) > ULN at day -1.
- In such a case, the assessment may be repeated once.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance CRU, Daytona Beach
Daytona Beach, Florida, 32117
About this study
Official title: A Double-blinded, Randomized, Controlled, Single Ascending Dose Study in Healthy Adult Volunteers to Assess the Safety and Pharmacokinetics of an Investigational Imaging Product
The objective of this study is to assess the safety and tolerability of ASP5354 administered intravenously as a single dose to healthy subjects. This study will also assess the single dose pharmacokinetics of ASP5354 in plasma and urine.
Read the detailed description
This is a study comprising of 5 cohorts (cohorts 1 to 5) of 6 healthy subjects in each cohort (4 in each ASP5354 cohort and 2 in each placebo cohort). If the data from cohorts 1 to 3 are sufficient to characterize safety, tolerability and pharmacokinetics and the assessed doses reach the expected urine ASP5354 concentration, the study may be ended without running the fourth or fifth cohorts.
- Conditions
- Healthy Subjects
- Being tested
- ASP5354, Placebo
- Keywords
- Tolerability, Pharmacokinetics, Safety, ASP5354
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP5354Drug
Intravenous
PlaceboDrug
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| ASP5354 Dose Escalation (5 Dose Levels) | Experimental | Healthy male and female subjects will be assigned to Cohorts 1-5. In each cohort, 4 subjects will be randomized to receive escalated doses of ASP5354. Each subject will receive a single intravenous bolus injection under fasting conditions. Receives: Drug: ASP5354 |
| Placebo Dose Escalation (5 Dose Levels) | Placebo comparator | Healthy male and female subjects will be assigned to Cohorts 1-5. In each cohort, two subjects will be randomized to receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)
An AE is any untoward medical occurrence in a participants administered ASP5354, and which does not necessarily have to have a causal relationship with this treatment. 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 whether or not considered related to the medicinal product.
AEs will be coded using MedDRA.
Measured: Up to Day 14
Number of participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Measured: Up to Day 7
Number of participants with vital sign abnormalities and /or AEs
Number of participants with potentially clinically significant vital sign values.
Measured: Up to Day 7
Safety and tolerability assessed by 12-lead electrocardiogram (ECG)
12-lead ECGs will be taken after the subject has been resting in the supine position for at least 5 minutes. 12 lead ECGs will be taken in triplicate.
Measured: Up to Day 7
Number of participants with physical exam abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant physical exam values.
Measured: Up to Day 7
Secondary outcomes (18)
Pharmacokinetics (PK) of ASP5354 in plasma: plasma concentration at time 0 (C0)
C0 will be derived from the PK samples collected.
Measured: Before dosing on Day 1
PK of ASP5354 in plasma: area under the concentration-time curve from time zero to 24 hours postdose (AUC0-24)
AUC0-24 will be derived from the PK samples collected.
Measured: Up to 24 hr after dosing
PK of ASP5354 in plasma: AUC extrapolated from time to infinity as a percentage of total area under the concentration-time curve (AUCinf)
AUCinf will be derived from the PK samples collected.
Measured: Up to 24 hr after dosing
PK of ASP5354 in plasma: AUC from time zero to the time of the last quantifiable concentration (AUClast)
AUClast will be derived from the PK samples collected.
Measured: Up to 24 hr after dosing
PK of ASP5354 in plasma: AUC extrapolated from time to infinity as a percentage of total area under the concentration-time curve (AUCinf(%extrap))
AUCinf (%extrap) will be derived from the PK samples collected.
Measured: Up to 24 hr after dosing
PK of ASP5354 in plasma: maximum concentration (Cmax)
Cmax will be derived from the PK samples collected.
Measured: Up to 24 hr after dosing
PK of ASP5354 in plasma: total body clearance of drug from plasma (CL)
CL will be derived from the PK samples collected.
Measured: Up to 24 hr after dosing
PK of ASP5354 in plasma: time of maximum concentration (tmax)
tmax will be derived from the PK samples collected.
Measured: Up to 24 hr after dosing
PK of ASP5354 in plasma: apparent terminal elimination half-life (t1/2)
t1/2 will be derived from the PK samples collected.
Measured: Up to 24 hr after dosing
PK of ASP5354 in plasma: volume of distribution during terminal phase (Vz)
Vz will be derived from the PK samples collected.
Measured: Up to 24 hr after dosing
PK of ASP5354 in urine: amount of unchanged drug excreted into the urine (Ae)
Ae will be derived from the PK samples collected.
Measured: Up to 24 hr after dosing
PK of ASP5354 in urine: percentage of dose excreted in the urine (Ae%)
Ae% will be derived from the PK samples collected.
Measured: Up to 24 hr after dosing
PK of ASP5354 in urine: cumulative amount of unchanged drug excreted into the urine (CumAe)
CumAe will be derived from the PK samples collected.
Measured: Up to 24 hr after dosing
PK of ASP5354 in urine: cumulative percentage of dose excreted in the urine (CumAe%)
CumAe% will be derived from the PK samples collected.
Measured: Up to 24 hr after dosing
PK of ASP5354 in urine: amount of unchanged drug excreted into the urine from time zero to the time of the last quantifiable concentration (Aelast)
Aelast will be derived from the PK samples collected.
Measured: Up to 24 hr after dosing
PK of ASP5354 in urine: percent of unchanged drug excreted into the urine from time zero to the time of the last quantifiable concentration (Aelast%)
Aelast% will be derived from the PK samples collected.
Measured: Up to 24 hr after dosing
PK of ASP5354 in urine: renal clearance (CLR)
CLR will be derived from the PK samples collected.
Measured: Up to 24 hr after dosing
PK of ASP5354 in urine: mean ASP5354 urine concentrations at each time point
Mean ASP5354 urine concentrations will be derived from the PK samples collected.
Measured: Up to 24 hr after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start25 Oct 2018
- Primary completion20 May 2019
- Study completion20 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698305
- Sponsor's protocol ID
- 5354-CL-0001
- Status last verified
- Apr 2020
- First submitted
- 4 Oct 2018
- Last updated
- 16 Oct 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/.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded, Randomized, Controlled, Single Ascending Dose Study in Healthy Adult Volunteers to Assess the Safety and Pharmacokinetics of an Investigational Imaging Product
- ClinicalTrials.gov ID
- NCT03698305
- Acronym / sponsor ID
- 5354-CL-0001
- Conditions
- Healthy Subjects
- Keywords
- Tolerability, Pharmacokinetics, Safety, ASP5354
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 9 Oct 2018 (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.
The objective of this study is to assess the safety and tolerability of ASP5354 administered intravenously as a single dose to healthy subjects. This study will also assess the single dose pharmacokinetics of ASP5354 in plasma and urine.
Detailed description
This is a study comprising of 5 cohorts (cohorts 1 to 5) of 6 healthy subjects in each cohort (4 in each ASP5354 cohort and 2 in each placebo cohort). If the data from cohorts 1 to 3 are sufficient to characterize safety, tolerability and pharmacokinetics and the assessed doses reach the expected urine ASP5354 concentration, the study may be ended without running the fourth or fifth cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASP5354 Dose Escalation (5 Dose Levels) | Experimental | Drug: ASP5354Healthy male and female subjects will be assigned to Cohorts 1-5. In each cohort, 4 subjects will be randomized to receive escalated doses of ASP5354. Each subject will receive a single intravenous bolus injection under fasting conditions. |
| Placebo Dose Escalation (5 Dose Levels) | Placebo comparator | Drug: PlaceboHealthy male and female subjects will be assigned to Cohorts 1-5. In each cohort, two subjects will be randomized to receive placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- A female subject is eligible to participate if she is not pregnant and at least one of the following conditions applies:
- Female subject must agree not to breastfeed starting at screening, throughout the study period and for 30 days after the final IP administration.
- Female subject must not donate ova starting at screening, throughout the study period and for 30 days after the final IP administration.
- Male subject with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 30 days after the final IP administration.
- Male subject must not donate sperm during the treatment period and for at least 30 days after the final IP administration.
Key exclusion criteria (21 listed)
- Subject has signs of urinary tract infection, abnormalities or disease or has had operational interventions on the urinary tract.
- Subject has received any IP within 28 days or 5 half-lives (if known), whichever is longer, prior to screening.
- 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 ASP5354 or any components of the formulation used.
- Subject has had previous exposure to ASP5354.
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 |
|---|---|---|
| ASP5354Intravenous | Drug | ASP5354 Dose Escalation (5 Dose Levels) |
| PlaceboIntravenous | Drug | Placebo Dose Escalation (5 Dose Levels) |
Primary outcome
Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)
Time frame: Up to Day 14
An AE is any untoward medical occurrence in a participants administered ASP5354, and which does not necessarily have to have a causal relationship with this treatment. 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 whether or not considered related to the medicinal product. AEs will be coded using MedDRA.
Number of participants with laboratory value abnormalities and/or AEs
Time frame: Up to Day 7
Number of participants with potentially clinically significant laboratory values.
Number of participants with vital sign abnormalities and /or AEs
Time frame: Up to Day 7
Number of participants with potentially clinically significant vital sign values.
Safety and tolerability assessed by 12-lead electrocardiogram (ECG)
Time frame: Up to Day 7
12-lead ECGs will be taken after the subject has been resting in the supine position for at least 5 minutes. 12 lead ECGs will be taken in triplicate.
Number of participants with physical exam abnormalities and/or adverse events (AEs)
Time frame: Up to Day 7
Number of participants with potentially clinically significant physical exam values.
18 secondary outcomes
Pharmacokinetics (PK) of ASP5354 in plasma: plasma concentration at time 0 (C0)
Time frame: Before dosing on Day 1
PK of ASP5354 in plasma: area under the concentration-time curve from time zero to 24 hours postdose (AUC0-24)
Time frame: Up to 24 hr after dosing
PK of ASP5354 in plasma: AUC extrapolated from time to infinity as a percentage of total area under the concentration-time curve (AUCinf)
Time frame: Up to 24 hr after dosing
PK of ASP5354 in plasma: AUC from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: Up to 24 hr after dosing
PK of ASP5354 in plasma: AUC extrapolated from time to infinity as a percentage of total area under the concentration-time curve (AUCinf(%extrap))
Time frame: Up to 24 hr after dosing
PK of ASP5354 in plasma: maximum concentration (Cmax)
Time frame: Up to 24 hr after dosing
PK of ASP5354 in plasma: total body clearance of drug from plasma (CL)
Time frame: Up to 24 hr after dosing
PK of ASP5354 in plasma: time of maximum concentration (tmax)
Time frame: Up to 24 hr after dosing
PK of ASP5354 in plasma: apparent terminal elimination half-life (t1/2)
Time frame: Up to 24 hr after dosing
PK of ASP5354 in plasma: volume of distribution during terminal phase (Vz)
Time frame: Up to 24 hr after dosing
PK of ASP5354 in urine: amount of unchanged drug excreted into the urine (Ae)
Time frame: Up to 24 hr after dosing
PK of ASP5354 in urine: percentage of dose excreted in the urine (Ae%)
Time frame: Up to 24 hr after dosing
PK of ASP5354 in urine: cumulative amount of unchanged drug excreted into the urine (CumAe)
Time frame: Up to 24 hr after dosing
PK of ASP5354 in urine: cumulative percentage of dose excreted in the urine (CumAe%)
Time frame: Up to 24 hr after dosing
PK of ASP5354 in urine: amount of unchanged drug excreted into the urine from time zero to the time of the last quantifiable concentration (Aelast)
Time frame: Up to 24 hr after dosing
PK of ASP5354 in urine: percent of unchanged drug excreted into the urine from time zero to the time of the last quantifiable concentration (Aelast%)
Time frame: Up to 24 hr after dosing
PK of ASP5354 in urine: renal clearance (CLR)
Time frame: Up to 24 hr after dosing
PK of ASP5354 in urine: mean ASP5354 urine concentrations at each time point
Time frame: Up to 24 hr after dosing
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 16 Oct 2024.
- Individual participant dataSharing planned: 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/.
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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 Global Development, Inc.
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 ASP5354 in people with Healthy Subjects, run by Astellas Pharma Global Development, Inc. 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 10 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: finished, as of the sponsor's last update on 16 Oct 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?
Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs) (time frame: Up to Day 14). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2024.