Healthy VolunteersPhase 1NCT02359032
A Combined Single and Multiple Ascending Dose Study of ASP6858 in Healthy Subjects
A Phase 1 study testing ASP6858 in people with Healthy Volunteers, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.
Trial summary
The purpose of this study is evaluate the safety and tolerability of single and multiple ascending oral doses of ASP6858. This study will also evaluate the pharmacokinetics (PK) of ASP6858 and its metabolites as well as the effect of food to the PK of ASP6858. 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?
- ASP6858
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Jan 2016
- 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
- Part 1: Healthy male subject, 18 to 55 years of age, inclusive, at screening. Part 2: Healthy male or female subject, 18 to 55 years of age, inclusive, at screening.
- Subject has a body mass index range of 18.5 to 30.0 kg/m2, inclusive, and weighs at least 50 kg, at screening.
- Subject has stable eating habits and weight (± 2 kg) over the last 4 weeks prior to screening.
- Subject is willing to comply strictly with the diet applied during the clinical study.
- Subject agrees not to participate in another interventional study while participating in the present clinical study, defined as signing the informed consent form until completion of the last study visit.
Who cannot join
- Subject had prior upper gastric, gastroduodenal, pancreatic or small intestinal surgery.
- Subject has lactose intolerance, gluten sensitivity or other condition with significant nutritional malabsorption.
- Female subject who has been pregnant within 6 months prior to screening assessment or breastfeeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to ASP6858 or any components of the formulations used.
- Subject has any of the liver chemistry tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, gamma glutamyl transferase, total bilirubin [TBL]) above the upper limit of normal (ULN). In such a case the assessment may be repeated once on day -1 (in part 2: treatment period 1 only).
- Subject has any clinically significant history of allergic conditions.
Show all 20Show fewer
- Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (noncutaneous) infection within 1 week prior to admission to the clinical unit (in part 2: treatment period 1 only).
- Subject has any clinically significant abnormality following the investigator's review of the physical examination, ECG and protocol-defined clinical laboratory tests at screening or admission to the clinical unit (in part 2: treatment period 1 only).
- Subject has a mean pulse < 40 or > 90 bpm; mean systolic blood pressure > 140 mmHg; mean diastolic blood pressure > 90 mmHg (vital signs measurements taken in triplicate after subject has been resting in supine position for 5 minutes; pulse will be measured automatically) at screening and day -1 (in part 2: treatment period 1 only). If the blood pressure exceeds the limits above, 1 additional triplicate can be taken.
- Subject has a mean corrected QT interval using Fridericia's formula > 430 ms (for male subjects) and > 450 ms (for female subjects) on day -1 (in part 2: treatment period 1 only). If these limits are exceeded, 1 additional triplicate ECG can be taken.
- Subject uses 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 paracetamol (up to 2 g/day) and except for use of contraceptives or hormone replacement therapy.
- Subject has a history of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the clinical unit (in part 2: first admission).
- Subject has a history of drinking more than 21 units (male subjects) or 14 units (female subjects) of alcohol per week (1 unit = 10 g pure alcohol = 250 mL of beer [5%] or 35 mL of spirits [35%] or 100 mL of wine [12%]) within 3 months prior to admission to the clinical unit (in part 2: first admission).
- Subject uses any drugs of abuse within 3 months prior to admission to the clinical unit (in part 2: first admission).
- Subject uses any inducer of metabolism (e.g., barbiturates, rifampin) in 1 month prior to admission to the clinical unit (in part 2: first admission).
- Subject had significant blood loss, donated 1 unit (500 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to admission to the clinical unit (in part 2: first admission).
- Subject has a positive serology test for hepatitis B surface antigen, hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies or antibodies to human immunodeficiency virus type 1 (HIV-1) and/or type 2 (HIV-2) at screening.
- Subject participated in any clinical study or has been treated with any investigational drugs within 3 months or 5 terminal half-lives, whichever is longer, prior to screening.
- Subject is unable to communicate, read and understand English, or has any other condition which, in the investigator's opinion, makes the subject unsuitable for clinical study participation.
- Subject is an employee of the Astellas Group, a Clinical Research Organization or other vendor involved in the clinical study.
Trial locations and contacts
1 site in 1 country.
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 ASP6858 in Healthy Subjects
The purpose of this study is evaluate the safety and tolerability of single and multiple ascending oral doses of ASP6858. This study will also evaluate the pharmacokinetics (PK) of ASP6858 and its metabolites as well as the effect of food to the PK of ASP6858. The study will also evaluate the pharmacodynamics of ASP6858.
Read the detailed description
This study has 2 parts: Part 1 is a placebo-controlled, single ascending dose study where male only subjects will be residential for 5-8 days (Part 1 will also include an open-label, food effect section); and Part 2 is a placebo-controlled, randomized, 2-way crossover, multiple ascending dose study where male and female subjects will be residential for 14-17 days for each treatment period. There will be a washout period between the 2 periods in Part 2.
- Conditions
- Healthy Volunteers
- Being tested
- ASP6858, Placebo
- Keywords
- Healthy subjects, Pharmacokinetics of ASP6858, ASP6858, Pharmacodynamics of ASP6858
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP6858Drug
Oral tablets
PlaceboDrug
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Part 1: ASP6858 single ascending dose | Experimental | ASP6858 arm Receives: Drug: ASP6858 |
| Part 1: Placebo single ascending dose | Placebo comparator | Placebo arm Receives: Drug: Placebo |
| Part 1: ASP6858 single ascending dose (fasting cohort) | Experimental | ASP6858 arm Receives: Drug: ASP6858 |
| Part 2, Sequence 1: ASP6858 multiple ascending dose & placebo | Experimental | ASP6858 and placebo arm Receives: Drug: ASP6858; Drug: Placebo |
| Part 2, Sequence 2: ASP6858 multiple ascending dose & placebo | Experimental | ASP6858 and placebo arm Receives: Drug: ASP6858; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by adverse events
Measured: Part 1 = up to 17 days; Part 2 = up to 50 days
Safety as assessed by vital signs
blood pressure, pulse rate, body temperature
Measured: Part 1 = up to 17 days; Part 2 = up to 50 days
Safety as assessed by clinical laboratory tests
Biochemistry, hematology, urinalysis
Measured: Part 1 = up to 17 days; Part 2 = up to 50 days
Safety as assessed by 12-lead electrocardiogram (ECG)
Measured: Part 1 = up to 17 days; Part 2 = up to 50 days
Safety as assessed by continuous cardiac monitoring
Part 1 = N/A for fasting cohort
Measured: Part 1 = Days 1-4; Part 2 = Day 10
Safety as assessed by coagulation parameters: aPTT, PT
Activated partial thromboplastin time (aPTT); Prothrombin time (PT)
Measured: Part 1 = up to 17 days; Part 2 = up to 50 days
Safety as assessed by body weight (Part 2)
Measured: up to 50 days
Secondary outcomes (9)
Secondary Outcome Title: Pharmacokinetic profile of ASP6858 (plasma): AUCinf, AUC5, AUC14, AUC24, AUClast, tlag, tmax, Cmax, t½, Vz/F, CL/F (Part 1)
Cumulative amount of study drug excreted into urine from time of dosing extrapolated to time infinity (AUCinf); Area under the concentration-time curve from the time of dosing to 5 hours postdose (AUC5); Area under the concentration-time curve from the time of dosing to 14 hours postdose (AUC14); Area under the concentration-time curve from the time of dosing to 24 hours postdose (AUC24); Area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast); Time prior to the time corresponding to the first measurable (nonzero) concentration (tlag); Time of maximum concentration (tmax); Maximum concentration (Cmax); Terminal elimination half-life (t1/2); Apparent volume of distribution during the terminal elimination phase after single or multiple extravascular dosing (Vz/F); Apparent total systemic clearance after single or multiple extravascular dosing (CL/F)
Measured: Day 1
Pharmacokinetic profile of ASP6858 metabolite M1 and M2 (plasma): AUCinf, AUC5, AUC14, AUC24, AUClast, tlag, tmax, Cmax, t½, MPR (Part 1)
Metabolite to parent ratio (MPR)
Measured: Day 1
Pharmacokinetic profile of ASP6858, metabolites M1 and M2 (urine): Ae24, Ae24%, Aelast, Aelast%, Aeinf, Aeinf%, CLR (Part 1)
Percentage of study drug excreted into urine from time of dosing to 24 hours postdose (Ae24%); Cumulative amount of study drug excreted into urine from time of dosing up to the collection time of the last measurable concentration (Aelast); Percentage of study drug dose excreted into urine from time of dosing up to the collection time of the last measurable concentration (Aelast%); Cumulative amount of study drug excreted into urine from time of dosing extrapolated to time infinity (Aeinf); Renal clearance (CLR)
Measured: Day 1
Pharmacokinetic profile of ASP6858 and metabolites M1 and M2 (plasma): Ctrough, morning (Part 2)
Concentration immediately prior to morning dosing (Ctrough, morning)
Measured: Days 3, 6 and 9
Pharmacokinetic profile of ASP6858 and metabolites M1 and M2 (plasma): tmax, Cmax, AUC5, PTR, AUC14, t1/2, AUC24 (Part 2)
Peak trough ratio (PTR)
Measured: Day 10
Pharmacokinetic profile of ASP6858 (plasma):Vz/F, CL/F
Measured: Day 10
Pharmacokinetic profile of ASP6858 metabolites M1 and M2 (plasma): MPR, MPR24
Metabolite to parent ratio from the time of dosing to 24 hours postdose (MPR24)
Measured: Day 10
Pharmacokinetic profile of ASP6858 and metabolites M1 and M2 (urine): Ae24, Ae24%, CLR,24
Measured: Day 10
Pharmacodynamic profile (urine): 24UUN and UNA
24-hour urinary urea nitrogen (24UUN); urinary nitrogen appearance (UNA)
Measured: Day 8-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359032
- Sponsor's protocol ID
- 6858-CL-0001
- Other IDs
- 2014-003735-18, 2014
- Status last verified
- May 2016
- First submitted
- 4 Feb 2015
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. 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 ASP6858 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02359032
- Acronym / sponsor ID
- 6858-CL-0001
- Conditions
- Healthy Volunteers
- Keywords
- Healthy subjects, Pharmacokinetics of ASP6858, ASP6858, Pharmacodynamics of ASP6858
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 Feb 2015 (estimated)
- 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 evaluate the safety and tolerability of single and multiple ascending oral doses of ASP6858. This study will also evaluate the pharmacokinetics (PK) of ASP6858 and its metabolites as well as the effect of food to the PK of ASP6858. The study will also evaluate the pharmacodynamics of ASP6858.
Detailed description
This study has 2 parts: Part 1 is a placebo-controlled, single ascending dose study where male only subjects will be residential for 5-8 days (Part 1 will also include an open-label, food effect section); and Part 2 is a placebo-controlled, randomized, 2-way crossover, multiple ascending dose study where male and female subjects will be residential for 14-17 days for each treatment period. There will be a washout period between the 2 periods in Part 2.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1: ASP6858 single ascending dose | Experimental | Drug: ASP6858ASP6858 arm |
| Part 1: Placebo single ascending dose | Placebo comparator | Drug: PlaceboPlacebo arm |
| Part 1: ASP6858 single ascending dose (fasting cohort) | Experimental | Drug: ASP6858ASP6858 arm |
| Part 2, Sequence 1: ASP6858 multiple ascending dose & placebo | Experimental | Drug: ASP6858, Drug: PlaceboASP6858 and placebo arm |
| Part 2, Sequence 2: ASP6858 multiple ascending dose & placebo | Experimental | Drug: ASP6858, Drug: PlaceboASP6858 and placebo arm |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Part 1: Healthy male subject, 18 to 55 years of age, inclusive, at screening. Part 2: Healthy male or female subject, 18 to 55 years of age, inclusive, at screening.
- Subject has a body mass index range of 18.5 to 30.0 kg/m2, inclusive, and weighs at least 50 kg, at screening.
- Subject has stable eating habits and weight (± 2 kg) over the last 4 weeks prior to screening.
- Subject is willing to comply strictly with the diet applied during the clinical study.
- Subject agrees not to participate in another interventional study while participating in the present clinical study, defined as signing the informed consent form until completion of the last study visit.
Key exclusion criteria (20 listed)
- Subject had prior upper gastric, gastroduodenal, pancreatic or small intestinal surgery.
- Subject has lactose intolerance, gluten sensitivity or other condition with significant nutritional malabsorption.
- Female subject who has been pregnant within 6 months prior to screening assessment or breastfeeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to ASP6858 or any components of the formulations used.
- Subject has any of the liver chemistry tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, gamma glutamyl transferase, total bilirubin [TBL]) above the upper limit of normal (ULN). In such a case the assessment may be repeated once on day -1 (in part 2: treatment period 1 only).
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 |
|---|---|---|
| ASP6858Oral tablets | Drug | Part 1: ASP6858 single ascending dose, Part 1: ASP6858 single ascending dose (fasting cohort), Part 2, Sequence 1: ASP6858 multiple ascending dose & placebo, Part 2, Sequence 2: ASP6858 multiple ascending dose & placebo |
| PlaceboOral tablets | Drug | Part 1: Placebo single ascending dose, Part 2, Sequence 1: ASP6858 multiple ascending dose & placebo, Part 2, Sequence 2: ASP6858 multiple ascending dose & placebo |
Primary outcome
Safety as assessed by adverse events
Time frame: Part 1 = up to 17 days; Part 2 = up to 50 days
Safety as assessed by vital signs
Time frame: Part 1 = up to 17 days; Part 2 = up to 50 days
blood pressure, pulse rate, body temperature
Safety as assessed by clinical laboratory tests
Time frame: Part 1 = up to 17 days; Part 2 = up to 50 days
Biochemistry, hematology, urinalysis
Safety as assessed by 12-lead electrocardiogram (ECG)
Time frame: Part 1 = up to 17 days; Part 2 = up to 50 days
Safety as assessed by continuous cardiac monitoring
Time frame: Part 1 = Days 1-4; Part 2 = Day 10
Part 1 = N/A for fasting cohort
Safety as assessed by coagulation parameters: aPTT, PT
Time frame: Part 1 = up to 17 days; Part 2 = up to 50 days
Activated partial thromboplastin time (aPTT); Prothrombin time (PT)
Safety as assessed by body weight (Part 2)
Time frame: up to 50 days
9 secondary outcomes
Secondary Outcome Title: Pharmacokinetic profile of ASP6858 (plasma): AUCinf, AUC5, AUC14, AUC24, AUClast, tlag, tmax, Cmax, t½, Vz/F, CL/F (Part 1)
Time frame: Day 1
Pharmacokinetic profile of ASP6858 metabolite M1 and M2 (plasma): AUCinf, AUC5, AUC14, AUC24, AUClast, tlag, tmax, Cmax, t½, MPR (Part 1)
Time frame: Day 1
Pharmacokinetic profile of ASP6858, metabolites M1 and M2 (urine): Ae24, Ae24%, Aelast, Aelast%, Aeinf, Aeinf%, CLR (Part 1)
Time frame: Day 1
Pharmacokinetic profile of ASP6858 and metabolites M1 and M2 (plasma): Ctrough, morning (Part 2)
Time frame: Days 3, 6 and 9
Pharmacokinetic profile of ASP6858 and metabolites M1 and M2 (plasma): tmax, Cmax, AUC5, PTR, AUC14, t1/2, AUC24 (Part 2)
Time frame: Day 10
Pharmacokinetic profile of ASP6858 (plasma):Vz/F, CL/F
Time frame: Day 10
Pharmacokinetic profile of ASP6858 metabolites M1 and M2 (plasma): MPR, MPR24
Time frame: Day 10
Pharmacokinetic profile of ASP6858 and metabolites M1 and M2 (urine): Ae24, Ae24%, CLR,24
Time frame: Day 10
Pharmacodynamic profile (urine): 24UUN and UNA
Time frame: Day 8-10
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 21 Jun 2016.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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 Director study director
Astellas Pharma Europe B.V.
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 ASP6858 in people with Healthy Volunteers, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.
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 5 inclusion and 20 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 21 Jun 2016. 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 Kingdom. 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 as assessed by adverse events (time frame: Part 1 = up to 17 days; Part 2 = up to 50 days). The study lists 7 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 21 Jun 2016.