Healthy Volunteers, Sjögren's Syndrome
Conditions
Keywords
ASP5502, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Food Effect
Brief summary
Primary Sjögren's syndrome (pSS) is a condition when the body's immune system attacks glands that produce fluids, such as the tear and saliva glands. This leads to dry eyes and a dry mouth. However, other symptoms may occur such as fatigue, joint pain, and skin problems. These symptoms can be severe. Symptoms can be treated but there is an unmet need to treat the actual condition. In this study, ASP5502 is being given to humans for the first time. The people taking part are healthy adults or adults with pSS. The main aims of the study are to check the safety of ASP5502 and how people tolerate ASP5502. This study will be in 3 parts. In Part 1, healthy men and women will take tablets of ASP5502 or a placebo just once. In this study, the placebo looks like the ASP5502 tablet but doesn't have any medicine in it. Different small groups of people will take a lower to a higher dose of ASP5502 or a placebo. This will happen one group after another. One small group will take tablets of ASP5502 or placebo with and without food. This is to find out if food affects how the body processes ASP5502. After their dose, people will stay in the medical center for a few nights. This is to have blood tests, electrocardiograms (ECGs) to check heart health, and other safety checks, and to report any medical problems. One of these checks is to have their heart continuously tracked during the first night. This is called telemetry. People who take tablets of ASP5502 or placebo with and without food will stay in the medical center for a few extra nights. In Part 2, healthy men and women will take tablets of ASP5502 or a placebo. They will do this once a day for 2 weeks (14 days). Different small groups of people will take a lower to a higher dose of ASP5502 or a placebo. This will happen one group after another. After taking ASP5502 or the placebo, people will stay in the medical center for a few nights. This is to have blood tests, ECGs to check heart health, and other safety checks, and to report any medical problems. Telemetry will also be done continuously during the first night. In Part 3, men and women with pSS will take tablets of ASP5502. They will do this once a day for 4 weeks (28 days). Different small groups of people will take a lower to a higher dose of ASP5502. This will either happen for one group after another, or just for 1 group. The number of groups and the doses taken will be worked out from the results from Part 1 and Part 2 of this study. People will stay in the medical center for a couple of nights. This will happen for their first dose, then again after about 2 weeks and 4 weeks of treatment. As in Parts 1 and 2, this is to have blood tests, ECGs to check heart health, and other safety checks, and to report any medical problems. In all parts of the study, people will return to the medical center about 1 week after their final blood sample is taken, for health check. People in parts 2 and 3 will also receive a telephone call safety check about 4 weeks after their last dose of ASP5502.
Detailed description
The study was terminated prior to enrolment into Part 3.
Interventions
DRUGASP5502
Oral
DRUGPlacebo
Oral
Sponsors
Astellas Pharma Global Development, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria for Healthy Participants * Participant is healthy and has no clinically significant medical conditions based on the review of the physical examination, ECG and protocol-defined clinical laboratory tests at screening or on day -2 or day -1. * Female participant is not pregnant and at least 1 of the following conditions apply: * Not a women of childbearing potential (WOCBP) * WOCBP who has a negative blood pregnancy test at screening and a urine pregnancy test on day -2 and agrees to follow the contraceptive guidance from the time of informed consent through at least 5 half-lives or 30 days, whichever is longer, after final study intervention administration. Female participants on hormonal contraceptives must also be using a double barrier method as defined in Contraceptive Requirements. * Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration. * Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration. * Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration. * Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration. * Male participant must not donate sperm during the treatment period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration. * Participant agrees not to participate in another interventional study while participating in the present study from the time of signing informed consent through the end of study visit. * Participant has a body mass index (BMI) range of 18.5 to 30.0 kg/m\^2 inclusive and weighs at least 50 kg for male and 40 kg for female at screening. Inclusion Criteria for Participants with pSS * Participant is diagnosed based on the 2016 American College of Rheumatology (ACR)- European Alliance of Associations for Rheumatology (EULAR) Classification Criteria for pSS. Diagnosis should have been established at least 6 months prior to day -1 and no clinically significant medical condition is present on the physical examination, ECG and protocol-defined clinical laboratory tests at screening or on day -1. * Female participant is not pregnant and at least 1 of the following conditions apply: * Not a WOCBP * WOCBP who has a negative blood pregnancy test at screening and a urine pregnancy test on day -1 and agrees to follow the contraceptive guidance from the time of informed consent through at least 5 half-lives or 30 days, whichever is longer, after final study intervention administration. Female participants on hormonal contraceptives are allowed ONLY if the participant also agrees to use a double barrier method (condom and spermicide) and the results from the 4β hydroxycholesterol assessment in Part 2 are negative. * WOCBP must also be using a double barrier method as defined in Contraceptive Requirements. * Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration. * Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration. * Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration. * Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration. * Male participant must not donate sperm during the treatment period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration. * Participant agrees not to participate in another interventional study while participating in the present study from the time of signing informed consent through the end of study visit. * Participant has a BMI range of 18.5 to 30.0 kg/m\^2 inclusive and weighs at least 50 kg for male and 40 kg for female at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to Day 58 | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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 study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures. |
| Number of participants with laboratory value abnormalities and/or AEs | Up to Day 38 | Number of participants with potentially clinically significant laboratory values. |
| Number of participants with vital sign abnormalities and/or AEs | Up to Day 38 | Number of participants with potentially clinically significant vital sign values. |
| Number of participants with 12-lead ECG abnormalities and/or AEs | Up to Day 38 | Number of participants with potentially clinically significant 12-lead ECG values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) of ASP5502 in plasma: maximum concentration (Cmax) | Up to Day 29 | Cmax will be recorded from the PK plasma samples collected. |
| PK of ASP5502 in plasma: area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast) [Part 1] | Up to Day 7 | AUClast will be recorded from the PK plasma samples collected. |
| PK of ASP5502 in plasma: area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf) [Part 1] | Up to Day 7 | AUCinf will be recorded from the PK plasma samples collected. |
| PK of ASP5502 in plasma: area under the concentration-time curve from time of dosing to 24 hours post dose (AUC24) [Part 2 & Part 3] | Up to Day 2 | AUC24 will be recorded from the PK plasma samples collected. |
| PK of ASP5502 in plasma: area under the concentration-time curve during a dosing interval, where tau is the length of the dosing interval (AUCtau) [Part 2 & Part 3] | Up to Day 29 | AUCtau will be recorded from the PK plasma samples collected. |
| PK of ASP5502 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough) [Part 2 & Part 3] | Up to Day 29 | Ctrough will be recorded from the PK plasma samples collected. |
| Change from baseline in concentration-QT [Part 1 & Part 2] | Baseline up to Day 20 | QT will be measured using ECG machine at site. Concentration will be recorded from PK plasma sample. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Astellas Pharma Global Development, Inc.
Outcome results
None listed