HealthyPhase 1NCT02820155
Phase I Single and Multiple Escalating Dose Study of RGN1016 in Healthy Male Subjects
A Phase 1 study testing RGN1016 in people with Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This is a double-blind, randomized, placebo-controlled, dose-escalating, single dose and multiple dose study. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- RGN1016
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2016to Feb 2017
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects may be entered in the study only if they meet all of the following criteria:
- Male with suitable veins for cannulation or repeated venipuncture, and must be able to swallow the study drug intact;
- Aged between 20 and 45 years (inclusive) at the screening visit;
- Has normal hematology results at screening visit;
- WBC: 3.54 ~ 9.06X10^3/μL
- RBC: 4 ~ 5.52X10^6/μL
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- hemoglobin: 13.2 ~17.2 g/dL
- hematocrit: 40.4 ~ 51.1%
- platelet: 148 ~ 339X10^3/μL
- Has normal biochemistry results at screening visit;
- alkaline phosphatase: 34 ~ 104 U/L
- total bilirubin: 0.3 ~ 1.0 mg/dL
- AST: 8 ~ 31 U/L
- ALT: 0 ~ 41 U/L
- BUN: 7 ~ 25 mg/dL
- creatinine: 0.6 ~ 1.3 mg/dL
- Normal coagulation results at screening visit;
- Prothrombin time/INR: 9.8 ~ 11.5 sec/0.92 ~ 1.09
- PTT: 25.6~32.6 sec
- Normal blood pressure (systolic blood pressure: 100 ~ 140 mmHg; diastolic blood pressure: 60 ~ 90 mmHg) at screening visit or prior to administration of investigational product;
- Able to provide written informed consent and willing to comply with the study protocol procedures and restrictions.
Who cannot join
- Subjects must not satisfy any of the following criteria:
- Has a body weight less than 50 kg and/or body mass index (BMI) less than 18 kg/m^2 or greater than 30 kg/m^2 at the screening visit. Body mass index is determined as total body weight/height^2 (kg/m^2);
- Is not in good general health as judged by the Investigator based on medical history, vital signs, physical examination, ECG, laboratory tests, and urinalysis at the screening visit or prior to administration of investigational product;
- Has a history or presence of any disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs at the screening visit or prior to administration of investigational product;
- Has a clinically significant psychiatric, renal, hepatic, cardiovascular, gastrointestinal, or neurologic disease at screening or prior to administration of investigational product;
- Is a smoker and/or has used nicotine-containing products within the last 6 months prior to the screening visit;
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- Has a history of alcohol and/or drug abuse;
- Participation of any clinical investigation during the last 60 days;
- Blood donation of more than 250 mL within the past 12 weeks;
- Excessive intake of caffeine containing drinks or food (more than 6 units of caffeine per day). One caffeine unit is contained in the following items: 1 (177.4 mL) cup of coffee, 2 (354.9 mL) cans of cola, 1 (354.9 mL) cup of tea, ½ (118.3 mL) cup of energy drink (e.g., PAOLYTA B Liq. or WHISBIH Liq.) or 3 oz of chocolate;
- Use of drugs with enzyme inducing properties such as St. John's Wort within 4 weeks prior to dosing;
- Has used prescription or nonprescription medication (except for occasional use of paracetamol and nasal spray) or herbal remedies or vitamins or minerals within 2 weeks or 5 half-lives of the drug, whichever is longer, prior to dosing;
- Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade, or other products containing grapefruit or Seville oranges within 7 days of the first administration of study medication;
- Male subjects who are unwilling to use barrier contraception in addition to having their partner use another method of contraception, for the duration of the study and for 3 months after dosing;
- Has a positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus (HIV);
- Has received a blood transfusion within the last 6 months at screening;
- Involved in the planning or conduct of the study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Ming-Jang Chiu, +886-2-2312-3456 ext. 65339, mjchiu@ntu.edu.tw
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Dose-Escalating, Single Dose and Multiple Dose Study to Evaluate the Safety and Pharmacokinetics of RGN1016 in Healthy Male Subjects
This is a double-blind, randomized, placebo-controlled, dose-escalating, single dose and multiple dose study.
Read the detailed description
This is a double-blind, randomized, placebo-controlled, dose-escalating study. The study comprises single dose (Stage I) and multiple dose (Stage II) stages. Stage II will not be initiated until completion of Stage I. The interim safety analysis report will be submitted to TFDA for an approval for proceeding to Stage II.
- Conditions
- Healthy
- Being tested
- RGN1016, Placebo
- Keywords
- Alzheimer's disease,cognitive function
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGN1016Drug
Stage I: single oral dose Stage II: multiple oral dose (QD, 7days)
PlaceboDrug
Stage I: single oral dose Stage II: multiple oral dose (QD, 7days)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Stage I: single oral dose Stage II: multiple oral dose (QD, 7days) Receives: Drug: Placebo |
| RGN1016_50mg | Experimental | Stage I: single oral dose Stage II: multiple oral dose (QD, 7days) Receives: Drug: RGN1016 |
| RGN1016_100mg | Experimental | Stage I: single oral dose Stage II: multiple oral dose (QD, 7days) Receives: Drug: RGN1016 |
| RGN1016_200mg | Experimental | Stage I: single oral dose Stage II: multiple oral dose (QD, 7days) Receives: Drug: RGN1016 |
| RGN1016_400mg | Experimental | Stage I: single oral dose Stage II: multiple oral dose (QD, 7days) Receives: Drug: RGN1016 |
| RGN1016_800mg | Experimental | Stage I: single oral dose Stage II: multiple oral dose (QD, 7days) Receives: Drug: RGN1016 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of incidence of Adverse Events.
Measured: up to14 days
Secondary outcomes (4)
Area under the plasma concentration-time curve (AUC)
Measured: 8 days
Time to peak drug concentration (Tmax)
Measured: 8 days
Maximum Plasma Concentration (Cmax)
Measured: 8 days
Half-life T1/2
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University
- Responsible party
- Sponsor
- Investigators
- Ming-Jang Chiu, Principal investigator, Neurology department of National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820155
- Sponsor's protocol ID
- 201412002MIPD
- Status last verified
- Jul 2016
- First submitted
- 3 Jun 2016
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Dose-Escalating, Single Dose and Multiple Dose Study to Evaluate the Safety and Pharmacokinetics of RGN1016 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02820155
- Acronym / sponsor ID
- 201412002MIPD
- Conditions
- Healthy
- Keywords
- Alzheimer's disease,cognitive function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University
- Study start
- Jun 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 30 Jun 2016 (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 double-blind, randomized, placebo-controlled, dose-escalating, single dose and multiple dose study.
Detailed description
This is a double-blind, randomized, placebo-controlled, dose-escalating study. The study comprises single dose (Stage I) and multiple dose (Stage II) stages. Stage II will not be initiated until completion of Stage I. The interim safety analysis report will be submitted to TFDA for an approval for proceeding to Stage II.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboStage I: single oral dose Stage II: multiple oral dose (QD, 7days) |
| RGN1016_50mg | Experimental | Drug: RGN1016Stage I: single oral dose Stage II: multiple oral dose (QD, 7days) |
| RGN1016_100mg | Experimental | Drug: RGN1016Stage I: single oral dose Stage II: multiple oral dose (QD, 7days) |
| RGN1016_200mg | Experimental | Drug: RGN1016Stage I: single oral dose Stage II: multiple oral dose (QD, 7days) |
| RGN1016_400mg | Experimental | Drug: RGN1016Stage I: single oral dose Stage II: multiple oral dose (QD, 7days) |
| RGN1016_800mg | Experimental | Drug: RGN1016Stage I: single oral dose Stage II: multiple oral dose (QD, 7days) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Male with suitable veins for cannulation or repeated venipuncture, and must be able to swallow the study drug intact;
- Aged between 20 and 45 years (inclusive) at the screening visit;
- Has normal hematology results at screening visit;
- Has normal biochemistry results at screening visit;
- Normal coagulation results at screening visit;
Key exclusion criteria (17 listed)
- Has a body weight less than 50 kg and/or body mass index (BMI) less than 18 kg/m^2 or greater than 30 kg/m^2 at the screening visit. Body mass index is determined as total body weight/height^2 (kg/m^2);
- Is not in good general health as judged by the Investigator based on medical history, vital signs, physical examination, ECG, laboratory tests, and urinalysis at the screening visit or prior to administration of investigational product;
- Has a history or presence of any disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs at the screening visit or prior to administration of investigational product;
- Has a clinically significant psychiatric, renal, hepatic, cardiovascular, gastrointestinal, or neurologic disease at screening or prior to administration of investigational product;
- Is a smoker and/or has used nicotine-containing products within the last 6 months prior to the screening visit;
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 |
|---|---|---|
| RGN1016Stage I: single oral dose Stage II: multiple oral dose (QD, 7days) | Drug | RGN1016_100mg, RGN1016_200mg, RGN1016_400mg, RGN1016_50mg, RGN1016_800mg |
| PlaceboStage I: single oral dose Stage II: multiple oral dose (QD, 7days) | Drug | Placebo |
Primary outcome
Number of incidence of Adverse Events.
Time frame: up to14 days
4 secondary outcomes
Area under the plasma concentration-time curve (AUC)
Time frame: 8 days
Time to peak drug concentration (Tmax)
Time frame: 8 days
Maximum Plasma Concentration (Cmax)
Time frame: 8 days
Half-life T1/2
Time frame: 8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Individual participant dataSharing planned: Undecided
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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.
Ming-Jang Chiu principal investigator
Neurology department of National Taiwan University Hospital
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 RGN1016 in people with Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
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 21 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 6 Jul 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming-Jang Chiu (+886-2-2312-3456 ext. 65339, mjchiu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of incidence of Adverse Events. (time frame: up to14 days). 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 6 Jul 2016.