Healthy Elderly Subjects (Age ≥55 Years)Phase 1NCT02342652
A Phase 1, 2-Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASLAN003 in Healthy Elderly Subjects
A Phase 1 study testing ASLAN003 in people with Healthy Elderly Subjects (Age ≥55 Years), run by ASLAN Pharmaceuticals at 1 site in Singapore.
Trial summary
This is a Phase 1, randomised, single-blind, placebo-controlled, 2 stage study design with 2 multiple dose cohorts of healthy elderly subjects. The purpose of the study is to determine the safety, tolerability and pharmacokinetics of ASLAN003 in healthy elderly male and female subjects. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Elderly Subjects (Age ≥55 Years)
- What is being tested?
- ASLAN003
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2014to Mar 2015
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- are capable of understanding and complying with the requirements of the study and have signed the informed consent form (ICF);
- are able to communicate well with the Investigator, and understand and comply with the requirements of the study;
- male or female subjects aged between 55 years and above;
- body mass index (BMI) in the range of 18 to 27 kg/m2, inclusive;
- healthy, as determined by pre study medical history, physical examinations, vital sign measurements, ECG (12 lead reporting RR, PR, QRS, corrected QT [QTc] using Fridericia's formulas [QTcF]) recordings with no evidence of clinically relevant medical disorders based on the opinion of the Investigator;
- whose out-of-normal range clinical laboratory test results are not clinically relevant and are acceptable to the Investigator;
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- whose results are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening;
- whose results are negative for drugs of abuse and alcohol tests at screening and admission to the study centre;
- non smoker or use of < 10 cigarettes (or equivalent nicotine-containing product) per day; (able to refrain from smoking during the study period
- male subjects must be willing to use barrier contraception during sexual intercourse, i.e. condoms, even if their partners are post-menopausal, surgically sterile or are using accepted contraceptive methods, from the first day of dose administrations until 3 months after the last dose administration;
Who cannot join
- have participated in a study involving another investigational device or drug study within 90 days prior to randomisation in this study;
- history of drug hypersensitivity reactions or hypersensitivity to drugs chemically related to the IP;
- history or evidence of a clinically significant disorder, condition or disease (including, but not limited to, cardiopulmonary, oncologic, autoimmune, immunogenic, renal, metabolic, haematological or psychiatric), that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
- existence of any surgical or medical condition which, in the judgement of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the IP;
- clinically significant history or evidence of any active or suspected bacterial, viral, fungal or parasitic infection within the 30 days prior to randomisation (e.g. common cold, viral syndrome, flu-like symptoms, etc.);
- active or recent history (within 30 days prior to randomisation) of acute viral infection of the skin (e.g. Herpes simplex, Molluscum contagiosum);
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- active or history of psoriasis, or a first-degree relative with active or history of psoriasis;
- known history or evidence of active or latent tuberculosis infection (e.g. positive tuberculin skin test showing induration >5 mm or positive tuberculin blood test) in absence of previous Bacillus Calmette Guerin vaccination, or recent exposure (within 6 months prior to randomisation in this study) to an individual with active tuberculosis or with intention to travel to a country with a high risk of tuberculosis during the study period (including the follow up period);
- history of autoimmune disease including but not limited to lupus, rheumatoid arthritis, autoimmune thyroid disease and immune thrombocytopenia;
- QTcF values higher than 450 ms at screening, unless assessed to be non-clinically significant by the Investigator or cardiologist;
- history of regular alcohol consumption (within 6 months prior to randomisation in this study), defined as: an average weekly intake of greater than 21 units or any average daily intake of greater than 3 units. One unit is equivalent to a half pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine;
- history of drug abuse within 1 year prior to the first day of dose administration, as judged by the Investigator and/or has a positive urine drug screen for substances of abuse including marijuana, cocaine, amphetamines, opiates, phencyclidine, barbiturates, benzodiazepines, propoxyphene, methadone metabolites, and cannabinoids and tricyclin anti-depressants at screening or on admission to the study centre;
- has donated plasma or blood or loss of more than 250 mL blood within 1 month prior to the first day of dose administration;
- is considering or has scheduled any surgical procedure during study participation;
- has received any type of vaccination within 30 days prior to randomisation in this study, or is planning to receive acellular, live or attenuated vaccines during the study;
- current use or history of use of any systemic immunomodulatory /immunosuppressive therapy, including but not restricted to systemic steroids within 3 months prior to randomisation in this study;
- requires treatment with any medication, either prescription or non-prescription, or herbal medications, within 14 days prior to the first dose of IP (exceptions are paracetamol or vitamin products at recommended daily doses);
- administration of any prescribed or over-the-counter drug within 2 weeks prior to screening, with the exception of paracetamol, which can be used during the study;
- current renal insufficiency ( defined as an estimated creatinine clearance of <60 mL/min as determined from the reference range of CGH laboratory report.)
- male subjects who plan to donate sperm in the 6 months following the receipt of IP;
- is judged by the Investigator or the Sponsor to be inappropriate for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomised, Single Blind, Placebo Controlled, 2-Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASLAN003 in Healthy Elderly Subjects
This is a Phase 1, randomised, single-blind, placebo-controlled, 2 stage study design with 2 multiple dose cohorts of healthy elderly subjects.
The purpose of the study is to determine the safety, tolerability and pharmacokinetics of ASLAN003 in healthy elderly male and female subjects.
Read the detailed description
This is a Phase 1, randomised, single-blind, placebo-controlled, 2 stage study design with 2 multiple dose cohorts of healthy elderly subjects.
Randomisation will be in a 3:1 ratio to ensure that 6 subjects receive ASLAN003 and 2 subjects receive placebo in a fed condition. Up to a maximum of 16 subjects (two cohorts) are planned in this study.
Subjects will be randomised to receive ASLAN003 100mg or matched placebo once daily for 14 consecutive days.
After 8 subjects have completed 14 days of dosing, the Investigator, and the Sponsor will review the available safety and PK data from all subjects before deciding to proceed with stage 2 of the study. In Stage 2, a further 8 subjects will be randomised to receive ASLAN003 100mg or matched placebo once daily for 14 consecutive days.
Following a screening visit that must fall within 28 days prior to the first dose of Investigational Product (IP) for both parts, subjects who qualify (according to the protocol-defined inclusion and exclusion criteria) will be admitted to the study centre on Day -1. Dose administration for each study part will commence on Day 1.
The subjects will stay at the study centre throughout the 14 days of dosing (D-1 toD15). Full PK blood collection will be done on D1, D8 and D14, and single trough PK blood collection on D4 and D11. All subjects will be discharged on D15 and asked to return for single PK blood sampling on D16, D17, D18, and D19 (+5days post-dose), with full outpatient visit including safety follow up and lab test on Day 19.
- Conditions
- Healthy Elderly Subjects (Age ≥55 Years)
- Being tested
- ASLAN003, Matched Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASLAN003Drug
Also called LAS186323
Healthy subject will be randomised to receive either ASLAN003 (N-aryl substituted aminoaryloic acid derivative), which is a DHODH inhibitor developed with the aim of improving several features of teriflunomide or the matching placebo as a negative control for each dose of ASLAN003 administered.
Matched PlaceboDrug
Healthy subject will be randomised to receive either ASLAN003 (N-aryl substituted aminoaryloic acid derivative), which is a DHODH inhibitor developed with the aim of improving several features of teriflunomide or the matching placebo as a negative control for each dose of ASLAN003 administered.
| Study group | Role | What they receive |
|---|---|---|
| ASLAN003 | Experimental | Substance: ASLAN003 Administration route: Oral. Dosage form: Hard gelatine 50 mg capsules. Frequency: 100 mg (2 capsules) once daily for 14 consecutive days Receives: Drug: ASLAN003 |
| Matched Placebo | Placebo comparator | Substance: Placebo Administration route: Oral Dosage form: Hard gelatine capsules Frequency: 2 capsules once daily for 14 consecutive days Receives: Drug: Matched Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (12 lead ECGs, physical examination, vital signs measurements, pulse rate, RR, body temperature, clinical laboratory assessments and recording of adverse events)
Safety assessments will include 12 lead ECGs, physical examination, vital signs measurements, pulse rate, RR, body temperature, clinical laboratory assessments and recording of adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Elderly Subjects (Age ≥55 Years)Studies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASLAN Pharmaceuticals
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Please contact ASLAN Pharmaceuticals, Study director, contact@aslanpharma.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342652
- Sponsor's protocol ID
- ASLAN003-002
- Status last verified
- Oct 2016
- First submitted
- 15 Jan 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomised, Single Blind, Placebo Controlled, 2-Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASLAN003 in Healthy Elderly Subjects
- ClinicalTrials.gov ID
- NCT02342652
- Acronym / sponsor ID
- ASLAN003-002
- Conditions
- Healthy Elderly Subjects (Age ≥55 Years)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- ASLAN PharmaceuticalsUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 Jan 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.
This is a Phase 1, randomised, single-blind, placebo-controlled, 2 stage study design with 2 multiple dose cohorts of healthy elderly subjects.
The purpose of the study is to determine the safety, tolerability and pharmacokinetics of ASLAN003 in healthy elderly male and female subjects.
Detailed description
This is a Phase 1, randomised, single-blind, placebo-controlled, 2 stage study design with 2 multiple dose cohorts of healthy elderly subjects.
Randomisation will be in a 3:1 ratio to ensure that 6 subjects receive ASLAN003 and 2 subjects receive placebo in a fed condition. Up to a maximum of 16 subjects (two cohorts) are planned in this study.
Subjects will be randomised to receive ASLAN003 100mg or matched placebo once daily for 14 consecutive days.
After 8 subjects have completed 14 days of dosing, the Investigator, and the Sponsor will review the available safety and PK data from all subjects before deciding to proceed with stage 2 of the study. In Stage 2, a further 8 subjects will be randomised to receive ASLAN003 100mg or matched placebo once daily for 14 consecutive days.
Following a screening visit that must fall within 28 days prior to the first dose of Investigational Product (IP) for both parts, subjects who qualify (according to the protocol-defined inclusion and exclusion criteria) will be admitted to the study centre on Day -1. Dose administration for each study part will commence on Day 1.
The subjects will stay at the study centre throughout the 14 days of dosing (D-1 toD15). Full PK blood collection will be done on D1, D8 and D14, and single trough PK blood collection on D4 and D11. All subjects will be discharged on D15 and asked to return for single PK blood sampling on D16, D17, D18, and D19 (+5days post-dose), with full outpatient visit including safety follow up and lab test on Day 19.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASLAN003 | Experimental | Drug: ASLAN003Substance: ASLAN003 Administration route: Oral. Dosage form: Hard gelatine 50 mg capsules. Frequency: 100 mg (2 capsules) once daily for 14 consecutive days |
| Matched Placebo | Placebo comparator | Drug: Matched PlaceboSubstance: Placebo Administration route: Oral Dosage form: Hard gelatine capsules Frequency: 2 capsules once daily for 14 consecutive days |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- are capable of understanding and complying with the requirements of the study and have signed the informed consent form (ICF);
- are able to communicate well with the Investigator, and understand and comply with the requirements of the study;
- male or female subjects aged between 55 years and above;
- body mass index (BMI) in the range of 18 to 27 kg/m2, inclusive;
- healthy, as determined by pre study medical history, physical examinations, vital sign measurements, ECG (12 lead reporting RR, PR, QRS, corrected QT [QTc] using Fridericia's formulas [QTcF]) recordings with no evidence of clinically relevant medical disorders based on the opinion of the Investigator;
Key exclusion criteria (21 listed)
- have participated in a study involving another investigational device or drug study within 90 days prior to randomisation in this study;
- history of drug hypersensitivity reactions or hypersensitivity to drugs chemically related to the IP;
- history or evidence of a clinically significant disorder, condition or disease (including, but not limited to, cardiopulmonary, oncologic, autoimmune, immunogenic, renal, metabolic, haematological or psychiatric), that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
- existence of any surgical or medical condition which, in the judgement of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the IP;
- clinically significant history or evidence of any active or suspected bacterial, viral, fungal or parasitic infection within the 30 days prior to randomisation (e.g. common cold, viral syndrome, flu-like symptoms, etc.);
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 |
|---|---|---|
| ASLAN003Also: LAS186323Healthy subject will be randomised to receive either ASLAN003 (N-aryl substituted aminoaryloic acid derivative), which is a DHODH inhibitor developed with the aim of improving several features of teriflunomide or the matching placebo as a negative control for each dose of ASLAN003 administered. | Drug | ASLAN003 |
| Matched PlaceboHealthy subject will be randomised to receive either ASLAN003 (N-aryl substituted aminoaryloic acid derivative), which is a DHODH inhibitor developed with the aim of improving several features of teriflunomide or the matching placebo as a negative control for each dose of ASLAN003 administered. | Drug | Matched Placebo |
Primary outcome
Safety (12 lead ECGs, physical examination, vital signs measurements, pulse rate, RR, body temperature, clinical laboratory assessments and recording of adverse events)
Time frame: 6 months
Safety assessments will include 12 lead ECGs, physical examination, vital signs measurements, pulse rate, RR, body temperature, clinical laboratory assessments and recording of adverse events
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 2 Nov 2016.
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.
Please contact ASLAN Pharmaceuticals study director
contact@aslanpharma.com
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 ASLAN003 in people with Healthy Elderly Subjects (Age ≥55 Years), run by ASLAN Pharmaceuticals at 1 site in Singapore.
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 2 Nov 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 Singapore. 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 (12 lead ECGs, physical examination, vital signs measurements, pulse rate, RR, body temperature, clinical laboratory assessments and recording of adverse events) (time frame: 6 months). 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 2 Nov 2016.