Healthy VolunteersPhase 1NCT04077879
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1617 in Healthy Adult Non-Asian and Japanese Subjects Including Assessment of a Food Effect
A Phase 1 study testing ASP1617 in people with Healthy Volunteers, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of single ascending oral doses of ASP1617 in healthy adult non-Asian and Japanese male and female participants. This study also evaluate the pharmacokinetics and determine the effect of food on the pharmacokinetics of a single oral dose of ASP1617. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ASP1617
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2019to 12 Jun 2021
- 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
- For cohorts that enroll non-Asian subjects, subject does not have East Asian (China, Hong Kong, Macau, Japan, Mongolia, North Korea, South Korea and Taiwan) ancestries.
- For cohorts that enroll Japanese subjects, subject is first generation Japanese, born in Japan with 4 grandparents of Japanese descent, and must have resided outside of Japan for ≤ 10 years.
- Subject has a body mass index (BMI) range of 18.5 to 32.0 kg/m2, inclusive and weighs at least 50 kg at screening.
- Female subject is not pregnant and at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP)
- WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after final investigational product (IP) administration.
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- Female subject must agree not to breastfeed starting at screening and throughout the study period and for 30 days after final IP administration.
- Female subject must not donate ova starting at first dose of IP and throughout the study period and for 30 days after final IP administration.
- Male subject with female partner(s) of child-bearing potential (including breastfeeding partner[s]) must agree to use contraception throughout the treatment period and for 30 days after final IP administration.
- Male subject must not donate sperm during the treatment period and for 30 days after final IP administration.
- Male subject with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 30 days after final IP administration.
- Subject agrees not to participate in another interventional study while participating in the present study.
Who cannot join
- Subject has received any 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 or breastfeeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to ASP1617 or any components of the formulation used.
- Subject has had previous exposure with ASP1617.
- Subject has any of the liver function tests (alkaline phosphatase [ALP], ALT, AST, gamma glutamyl transferase and TBL) above the upper linit of normal (ULN) on day -1. In such a case, the assessment may be repeated once.
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- Subject has creatinine level outside normal limits on 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 first 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 or fungal infection within 1 week prior to day -1.
- Subject has any clinically significant abnormality following the physical examination, 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) on day -1. If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
- Subject has a mean QTcF of > 430 msec (for male subjects) and > 450 msec (for female subjects) on day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG may be taken.
- Subject has used any prescribed or nonprescribed drugs in the 2 weeks prior to first IP administration, except for occasional use of acetaminophen (up to 2 g/day) topical dermatological products, including corticosteroid products, hormonal contraceptives or hormone replacement therapy (HRT).
- Subject has smoked, used tobacco-containing products and nicotine or nicotine-containing products (e.g., electronic vapes) within 6 months prior to screening.
- Subject has a history of consuming > 14 units for male subjects or > 7 units for female subjects of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within 2 years prior to screening or the subject tests positive for alcohol at screening or on day -1.
- Subject has used any drugs of abuse within 3 months prior to day -1 or the subject tests positive for drugs of abuse at screening or on day -1.
- Subject has used any inducer of metabolism in the 3 months prior to day -1.
- Subject has had significant blood loss, donated ≥ 1 unit (450 mL) of whole blood or donated plasma within 7 days prior to day -1 and/or received a transfusion of any blood or blood products within 60 days.
- Subject has a positive serology test for hepatitis A virus (HAV) antibodies, hepatitis B surface antigen (HBsAg), 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, the study-related contract research organizations (CROs) or the clinical unit.
- Subject has received any Coronavirus Disease 2019 (COVID-19) vaccines within 14 days prior to first IP administration.
- Subject has received any Coronavirus Disease 2019 (COVID-19) vaccines within 14 days prior to first IP administration.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Clinical Trials Medical Group / Parexel
Glendale, California, 91206
About this study
Official title: A Phase 1 Combined Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1617 in Healthy Adult Non-Asian and Japanese Subjects Including an Assessment of a Food Effect
The purpose of this study is to evaluate the safety and tolerability of single ascending oral doses of ASP1617 in healthy adult non-Asian and Japanese male and female participants.
This study also evaluate the pharmacokinetics and determine the effect of food on the pharmacokinetics of a single oral dose of ASP1617.
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 8 days/7 nights in Part 1: single ascending dose, and 21 days/20 nights in Part 2 multiple ascending dose.
- Conditions
- Healthy Volunteers
- Being tested
- ASP1617, Placebo
- Keywords
- ASP1617, Food Effect, Pharmacokinetics, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP1617Drug
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Single ascending dose of ASP1617 | Experimental | This is composed of 5 sequential cohorts (cohorts 1.1 to 1.5), 6-9 participants for each cohort, consisting of either only non-Asians in cohorts 1.1 and 1.2; or non-Asians plus Japanese in cohorts 1.3, 1.4 and 1.5). Participants in cohorts 1.1, 1.2, 1.3, 1.4 and 1.5 will receive a single dose of 2, 10, 30, 100 and 300 milligrams (mg) ASP1617 capsules respectively under fasting conditions Receives: Drug: ASP1617 |
| Single ascending dose of Placebo | Placebo comparator | Participants (2-3 for each cohort, consisting of either only non-Asians in cohorts 1.1 and 1.2; or non-Asians plus Japanese in cohorts 1.3, 1.4 and 1.5) will receive a single dose of matching placebo under fasting conditions. Receives: Drug: Placebo |
| Single dose of ASP1617 (Food Effect) | Experimental | Participants (6 Japanese and 3 non-Asian) will receive a single dose of 100 mg ASP1617 with a high-fat meal. Dosing of the Food Effect cohort will commence after having established the safety and tolerability of the dose tested in cohort 1.4. Receives: Drug: ASP1617 |
| Multiple ascending dose of ASP1617 | Experimental | This is composed of 3 sequential cohorts (cohorts 2.1 to 2.3, 9 participants for each cohort, consisting of only non-Asians in cohort 2.1, or non-Asians plus Japanese in cohorts 2.2 and 2.3). Participants in cohorts 2.1, 2.2 and 2.3 will receive 30, 60 and 110 mg ASP1617 capsules respectively twice daily for 14 consecutive days at the same dose level.
Based on safety, tolerability and pharmacokinetic data of Part 1, once daily or twice daily dosing will be selected. Receives: Drug: ASP1617 |
| Multiple ascending dose of Placebo | Placebo comparator | Participants (3 for each cohort, consisting of either only non-Asians in cohort 2.1, or non-Asians plus Japanese in cohort 2.2 and 2.3) will receive matching Placebo for 14 consecutive days at the same dose level in cohort 2.1 to 2.3. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) in Part 1
An AE is any untoward medical occurrence in a subject administered an investigational product (IP) 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 IP whether or not considered related to the IP.
AE is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.
An AE with onset at any time from first dosing until last scheduled procedure will be classified as a treatment-emergent adverse event (TEAE). A drug-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator, or records where the relationship is missing.
Measured: Up to Day 16
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
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
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
Number of participants with AEs in Part 2
An AE is any untoward medical occurrence in a subject administered an IP 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 IP whether or not considered related to the IP.
AE is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.
An AE with onset at any time from first dosing until last scheduled procedure will be classified as a TEAE. A drug-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator, or records where the relationship is missing.
Measured: Up to Day 29
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 29
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 29
Number of participants with 12-ECG abnormalities and/or AEs in Part 2
Number of participants with potentially clinically significant 12-ECG values.
Measured: Up to Day 29
Secondary outcomes (8)
Part 1: Pharmacokinetics (PK) of ASP1617 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 Day 7
Part 1: PK of ASP1617 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 Day 7
Part 1: PK of ASP1617 in plasma: maximum concentration (Cmax)
Cmax will be recorded from the PK plasma samples collected.
Measured: Up to Day 7
Part 2 (first dose): PK of ASP1617 in plasma: AUC from the time of dosing to 12 hours (AUC12)
AUC12 will be recorded from the PK plasma samples collected.
Measured: Up to 12 hours
Part 2 (first dose and last dose): PK of ASP1617 in plasma: Cmax
Cmax will be recorded from the PK plasma samples collected.
Measured: Up to Day 17
Part 2 (last dose): PK of ASP1617 in plasma: AUC during a dosing interval, where tau(τ) is the length of the dosing interval (AUCtau)
AUCtau will be recorded from the PK plasma samples collected.
Measured: Up to Day 17
Part 2 (last dose): PK of ASP1617 in plasma: accumulation ratio calculated using AUC (Rac(AUC))
Rac(AUC) will be recorded from the PK plasma samples collected.
Measured: Up to Day 17
PK of ASP1617 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough)
Ctrough will be recorded from the PK plasma samples collected.
Measured: Up to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start19 Sep 2019
- Primary completion12 Jun 2021
- Study completion12 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077879
- Sponsor's protocol ID
- 1617-CL-1001
- Status last verified
- Oct 2024
- First submitted
- 1 Sep 2019
- Last updated
- 23 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/.
Publications
Kojima T, Chen W, Smulders R, Stanhope S, Kowalski D, Heo N, Moy S, Goldston A, Han D, Zhu T. First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP1617, a Cathepsin-S Inhibitor, in Healthy Adult Subjects. Clin Transl Sci. 2026 Feb;19(2):e70460. doi: 10.1111/cts.70460.
PubMed 41577633
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. 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, Pharmacokinetics and Pharmacodynamics of ASP1617 in Healthy Adult Non-Asian and Japanese Subjects Including an Assessment of a Food Effect
- ClinicalTrials.gov ID
- NCT04077879
- Acronym / sponsor ID
- 1617-CL-1001
- Conditions
- Healthy Volunteers
- Keywords
- ASP1617, Food Effect, Pharmacokinetics, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 12 Jun 2021 (actual)
- Study completion
- 12 Jun 2021 (actual)
- First posted
- 4 Sep 2019 (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 purpose of this study is to evaluate the safety and tolerability of single ascending oral doses of ASP1617 in healthy adult non-Asian and Japanese male and female participants.
This study also evaluate the pharmacokinetics and determine the effect of food on the pharmacokinetics of a single oral dose of ASP1617.
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 8 days/7 nights in Part 1: single ascending dose, and 21 days/20 nights in Part 2 multiple ascending dose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Single ascending dose of ASP1617 | Experimental | Drug: ASP1617This is composed of 5 sequential cohorts (cohorts 1.1 to 1.5), 6-9 participants for each cohort, consisting of either only non-Asians in cohorts 1.1 and 1.2; or non-Asians plus Japanese in cohorts 1.3, 1.4 and 1.5). Participants in cohorts 1.1, 1.2, 1.3, 1.4 and 1.5 will receive a single dose of 2, 10, 30, 100 and 300 milligrams (mg) ASP1617 capsules respectively under fasting conditions |
| Single ascending dose of Placebo | Placebo comparator | Drug: PlaceboParticipants (2-3 for each cohort, consisting of either only non-Asians in cohorts 1.1 and 1.2; or non-Asians plus Japanese in cohorts 1.3, 1.4 and 1.5) will receive a single dose of matching placebo under fasting conditions. |
| Single dose of ASP1617 (Food Effect) | Experimental | Drug: ASP1617Participants (6 Japanese and 3 non-Asian) will receive a single dose of 100 mg ASP1617 with a high-fat meal. Dosing of the Food Effect cohort will commence after having established the safety and tolerability of the dose tested in cohort 1.4. |
| Multiple ascending dose of ASP1617 | Experimental | Drug: ASP1617This is composed of 3 sequential cohorts (cohorts 2.1 to 2.3, 9 participants for each cohort, consisting of only non-Asians in cohort 2.1, or non-Asians plus Japanese in cohorts 2.2 and 2.3). Participants in cohorts 2.1, 2.2 and 2.3 will receive 30, 60 and 110 mg ASP1617 capsules respectively twice daily for 14 consecutive days at the same dose level. Based on safety, tolerability and pharmacokinetic data of Part 1, once daily or twice daily dosing will be selected. |
| Multiple ascending dose of Placebo | Placebo comparator | Drug: PlaceboParticipants (3 for each cohort, consisting of either only non-Asians in cohort 2.1, or non-Asians plus Japanese in cohort 2.2 and 2.3) will receive matching Placebo for 14 consecutive days at the same dose level in cohort 2.1 to 2.3. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- For cohorts that enroll non-Asian subjects, subject does not have East Asian (China, Hong Kong, Macau, Japan, Mongolia, North Korea, South Korea and Taiwan) ancestries.
- For cohorts that enroll Japanese subjects, subject is first generation Japanese, born in Japan with 4 grandparents of Japanese descent, and must have resided outside of Japan for ≤ 10 years.
- Subject has a body mass index (BMI) range of 18.5 to 32.0 kg/m2, inclusive and weighs at least 50 kg at screening.
- Female subject is not pregnant and at least 1 of the following conditions apply:
- Female subject must agree not to breastfeed starting at screening and throughout the study period and for 30 days after final IP administration.
Key exclusion criteria (23 listed)
- Subject has received any 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 or breastfeeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to ASP1617 or any components of the formulation used.
- Subject has had previous exposure with ASP1617.
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 |
|---|---|---|
| ASP1617Oral | Drug | Multiple ascending dose of ASP1617, Single ascending dose of ASP1617, Single dose of ASP1617 (Food Effect) |
| PlaceboOral | Drug | Multiple ascending dose of Placebo, Single ascending dose of Placebo |
Primary outcome
Number of participants with adverse events (AEs) in Part 1
Time frame: Up to Day 16
An AE is any untoward medical occurrence in a subject administered an investigational product (IP) 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 IP whether or not considered related to the IP. AE is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event. An AE with onset at any time from first dosing until last scheduled procedure will be classified as a treatment-emergent adverse event (TEAE). A drug-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator, or records where the relationship is missing.
Number of participants with laboratory value abnormalities and/or AEs in Part 1
Time frame: Up to Day 16
Number of participants with potentially clinically significant laboratory values.
Number of participants with vital sign abnormalities and/or AEs in Part 1
Time frame: Up to Day 16
Number of participants with potentially clinically significant vital sign values.
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs in Part 1
Time frame: Up to Day 16
Number of participants with potentially clinically significant 12-ECG values.
Number of participants with AEs in Part 2
Time frame: Up to Day 29
An AE is any untoward medical occurrence in a subject administered an IP 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 IP whether or not considered related to the IP. AE is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event. An AE with onset at any time from first dosing until last scheduled procedure will be classified as a TEAE. A drug-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator, or records where the relationship is missing.
Number of participants with laboratory value abnormalities and/or AEs in Part 2
Time frame: Up to Day 29
Number of participants with potentially clinically significant laboratory values.
Number of participants with vital sign abnormalities and /or AEs in Part 2
Time frame: Up to Day 29
Number of participants with potentially clinically significant vital sign values.
Number of participants with 12-ECG abnormalities and/or AEs in Part 2
Time frame: Up to Day 29
Number of participants with potentially clinically significant 12-ECG values.
8 secondary outcomes
Part 1: Pharmacokinetics (PK) of ASP1617 in plasma: area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)
Time frame: Up to Day 7
Part 1: PK of ASP1617 in plasma: AUC from the time of dosing to the last measurable concentration (AUClast)
Time frame: Up to Day 7
Part 1: PK of ASP1617 in plasma: maximum concentration (Cmax)
Time frame: Up to Day 7
Part 2 (first dose): PK of ASP1617 in plasma: AUC from the time of dosing to 12 hours (AUC12)
Time frame: Up to 12 hours
Part 2 (first dose and last dose): PK of ASP1617 in plasma: Cmax
Time frame: Up to Day 17
Part 2 (last dose): PK of ASP1617 in plasma: AUC during a dosing interval, where tau(τ) is the length of the dosing interval (AUCtau)
Time frame: Up to Day 17
Part 2 (last dose): PK of ASP1617 in plasma: accumulation ratio calculated using AUC (Rac(AUC))
Time frame: Up to Day 17
PK of ASP1617 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough)
Time frame: Up to Day 17
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 23 Oct 2024.
- Derived from this study: PubMed 41577633Kojima T, Chen W, Smulders R, Stanhope S, Kowalski D, Heo N, Moy S, Goldston A, Han D, Zhu T. First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP1617, a Cathepsin-S Inhibitor, in Healthy Adult Subjects. Clin Transl Sci. 2026 Feb;19(2):e70460. doi: 10.1111/cts.70460.
- 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.
Senior Director 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 ASP1617 in people with Healthy Volunteers, 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 12 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 23 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?
Number of participants with adverse events (AEs) in Part 1 (time frame: Up to Day 16). The study lists 8 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 NCT04077879, 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 23 Oct 2024.