Healthy VolunteersPhase 1NCT02134964
Phase 1 Safety and PK Study of OLT1177 Capsules
A Phase 1 study testing OLT1177 Capsules in people with Healthy Volunteers, run by Olatec Therapeutics, Inc. at 1 site in United States.
Trial summary
This study is a randomized, placebo-controlled, sequential ascending-dose study of healthy volunteers after administration of single or multiple dose(s) of investigational drug (OLT1177 Caps or Placebo Caps). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- OLT1177 Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2014
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 60 years old, inclusive
- In good health as determined by the Investigator based on subject's medical history, ECG and physical examination at Baseline and safety laboratory tests (chemistry, hematology, coagulation and urinalysis) at Screening
- Normal blood pressure of 130/85 mmHg or lower
- Ability to provide written, informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the Investigator, to comply with all the requirements of the study
Who cannot join
- Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential who:
- Are or intend to become pregnant (including use of fertility drugs) during the study
- Are nursing
- Are not using an acceptable, highly effective method of contraception until all follow-up procedures are complete. (Acceptable, highly effective forms of contraception are defined as: oral contraception, intrauterine device, systemic [injectable or patch] contraception, double barrier methods, naturally or surgically sterile, strict abstinence or partner has been sterilized. If hormonal-based birth control is being used, subject or subject's sexual partner(s) must be on a stable-dose for ≥ 3 months prior to the Baseline visit and maintained at the same dosing level throughout the study.)
- Use of any drug treatment at the time of the study (with the exception of 81 mg aspirin and prescription oral or systemic contraceptives)
- Taking any prescription medications (other than oral or systemic contraceptives) within 14 days prior to administration of investigational drug or taking any over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 14 days prior to administration of investigational drug, except for topical products without systemic absorption
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- Use of NSAIDs or other prescription pain medication, more than once or twice a week, especially if taken for chronic or frequently recurring headache
- Active infection within 3 days of the Baseline visit
- History of or known positive for HIV, Hepatitis B surface antigen (HBsAg) or antibodies to Hepatitis C Virus (HCV)
- Diagnosed with any form of internal cancer within the past 5 years
- Any other medical conditions, diseases or prior surgeries that in the opinion of the Investigator would impair the subject from safely participating in the trial and/or completing any protocol requirements
- History of anaphylactic reactions to any systemic or topical compounds
- Have donated plasma (500 mL) within 7 days prior to drug administration
- Have donated or lost whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows: 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL of whole blood within 56 days prior to drug administration
- Is a user of any nicotine products (including chewing tobacco, snuff and/or e-cigarettes)
- Is not willing to restrict food or beverage including: alcohol, caffeine, poppy seeds, xanthine derivatives or xanthine-related compounds, energy drinks, natural health products, grapefruit juice, pomelo, Seville orange and marmalade use during the study as specified in Section 7.1.5
- Is lactose intolerant
- Is unable or unwilling to consume products containing bovine byproducts
- Is unable to adhere to or understand the requirements of the protocol
- If continuing on to Part B, subject is unable or unwilling to ingest the full study-provided high-fat breakfast within 30 minutes
- Enrollment in any trial and/or use of any Investigational Drug or device within the immediate 30-day period prior to the Baseline visit
- Enrollment in any study previously sponsored by Olatec Industries LLC, specifically Study OLT1177-01, Study OLT1177-02 or Study OLT1177-03
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Dose Escalation, Single Center, Safety and Pharmacokinetic Study of Single and Multi-Dose, Orally Administered OLT1177 Capsules in Healthy Subjects
This study is a randomized, placebo-controlled, sequential ascending-dose study of healthy volunteers after administration of single or multiple dose(s) of investigational drug (OLT1177 Caps or Placebo Caps). A total of 36 subjects will be enrolled across 6 cohorts, and subjects in each cohort will be randomized in a ratio of 5 active to 1 placebo.
- Conditions
- Healthy Volunteers
- Being tested
- OLT1177 Capsules, Placebo Capsules
- Keywords
- Safety, Tolerability, Pharmacokinetics, Dose escalation, Randomized, Healthy volunteers, OLT1177, Olatec
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLT1177 CapsulesDrug
OLT1177 Capsules are an experimental drug.
Placebo CapsulesDrug
Placebo Capsules are identical in all ways to the study drug, but contain no active pharmaceutical ingredient.
| Study group | Role | What they receive |
|---|---|---|
| OLT1177 Capsules | Experimental | A total of 5 patients in each cohort will receive OLT1177 Capsules:
* Cohort 1 will receive a single 100 mg dose of OLT1177
* Cohort 2 will receive a single 300 mg dose of OLT1177
* Cohort 3 will receive two 1000 mg doses of OLT1177 (seven days apart)
* Cohort 4 will receive 100 mg doses of OLT1177 QD for 8 days
* Cohort 5 will receive 300 mg doses of OLT1177 QD for 8 days
* Cohort 6 will receive 1000 mg doses of OLT1177 QD for 8 days Receives: Drug: OLT1177 Capsules |
| Placebo Capsules | Placebo comparator | A total of 1 patient in each cohort will receive Placebo Capsules:
* Cohort 1 will receive a single placebo capsule
* Cohort 2 will receive three placebo capsules
* Cohort 3 will receive ten placebo capsules (seven days apart)
* Cohort 4 will receive a single placebo capsule QD for 8 days
* Cohort 5 will receive three placebo capsules QD for 8 days
* Cohort 6 will receive ten placebo capsules QD for 8 days Receives: Drug: Placebo Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recording of adverse events
Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the event.
Measured: Screening through Day 28 follow-up
Secondary outcomes (4)
Safety Laboratory Measurements
Blood samples will be drawn and analyzed for: chemistry, hematology, lipids and coagulation.
Measured: Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
Electrocardiogram
Electrocardiograms will be captured and analyzed for changes throughout the duration of the study.
Measured: Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
Vital Signs
Vital signs (pulse, resting blood pressure, temperature and respirations) will be recorded and analyzed for changes throughout the duration of the study.
Measured: Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
Physical Examination
Physical examinations will be conducted to assess changes in subject health throughout the duration of the study.
Measured: Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionDec 2014
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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olatec Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Terry M Jones, MD, FAAD, Principal investigator, J&S Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134964
- Sponsor's protocol ID
- OLT1177-04
- Status last verified
- Mar 2015
- First submitted
- 7 May 2014
- Last updated
- 6 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Dose Escalation, Single Center, Safety and Pharmacokinetic Study of Single and Multi-Dose, Orally Administered OLT1177 Capsules in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02134964
- Acronym / sponsor ID
- OLT1177-04
- Conditions
- Healthy Volunteers
- Keywords
- Safety, Tolerability, Pharmacokinetics, Dose escalation, Randomized, Healthy volunteers, OLT1177, Olatec
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Olatec Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 May 2014 (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 study is a randomized, placebo-controlled, sequential ascending-dose study of healthy volunteers after administration of single or multiple dose(s) of investigational drug (OLT1177 Caps or Placebo Caps). A total of 36 subjects will be enrolled across 6 cohorts, and subjects in each cohort will be randomized in a ratio of 5 active to 1 placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OLT1177 Capsules | Experimental | Drug: OLT1177 CapsulesA total of 5 patients in each cohort will receive OLT1177 Capsules: * Cohort 1 will receive a single 100 mg dose of OLT1177 * Cohort 2 will receive a single 300 mg dose of OLT1177 * Cohort 3 will receive two 1000 mg doses of OLT1177 (seven days apart) * Cohort 4 will receive 100 mg doses of OLT1177 QD for 8 days * Cohort 5 will receive 300 mg doses of OLT1177 QD for 8 days * Cohort 6 will receive 1000 mg doses of OLT1177 QD for 8 days |
| Placebo Capsules | Placebo comparator | Drug: Placebo CapsulesA total of 1 patient in each cohort will receive Placebo Capsules: * Cohort 1 will receive a single placebo capsule * Cohort 2 will receive three placebo capsules * Cohort 3 will receive ten placebo capsules (seven days apart) * Cohort 4 will receive a single placebo capsule QD for 8 days * Cohort 5 will receive three placebo capsules QD for 8 days * Cohort 6 will receive ten placebo capsules QD for 8 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 to 60 years old, inclusive
- In good health as determined by the Investigator based on subject's medical history, ECG and physical examination at Baseline and safety laboratory tests (chemistry, hematology, coagulation and urinalysis) at Screening
- Normal blood pressure of 130/85 mmHg or lower
- Ability to provide written, informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the Investigator, to comply with all the requirements of the study
Key exclusion criteria (22 listed)
- Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential who:
- Use of any drug treatment at the time of the study (with the exception of 81 mg aspirin and prescription oral or systemic contraceptives)
- Taking any prescription medications (other than oral or systemic contraceptives) within 14 days prior to administration of investigational drug or taking any over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 14 days prior to administration of investigational drug, except for topical products without systemic absorption
- Use of NSAIDs or other prescription pain medication, more than once or twice a week, especially if taken for chronic or frequently recurring headache
- Active infection within 3 days of the Baseline 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 |
|---|---|---|
| OLT1177 CapsulesOLT1177 Capsules are an experimental drug. | Drug | OLT1177 Capsules |
| Placebo CapsulesPlacebo Capsules are identical in all ways to the study drug, but contain no active pharmaceutical ingredient. | Drug | Placebo Capsules |
Primary outcome
Recording of adverse events
Time frame: Screening through Day 28 follow-up
Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the event.
4 secondary outcomes
Safety Laboratory Measurements
Time frame: Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
Electrocardiogram
Time frame: Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
Vital Signs
Time frame: Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
Physical Examination
Time frame: Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
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 6 Mar 2015.
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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.
Terry M Jones, MD, FAAD principal investigator
J&S Studies
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 OLT1177 Capsules in people with Healthy Volunteers, run by Olatec Therapeutics, 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 4 inclusion and 22 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 6 Mar 2015. 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?
Recording of adverse events (time frame: Screening through Day 28 follow-up). 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 Mar 2015.