Healthy SubjectsPhase 1NCT03712163
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Norketotifen in Healthy Subjects
A Phase 1 study testing Norketotifen Oral Capsule (Cohort 1), Norketotifen Oral Capsule (Cohort 2) and Norketotifen Oral Capsule (Cohort 3) in people with Healthy Subjects, run by Emergo Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 1, single-center, double-blind, randomized, placebo-controlled, 2-part, single ascending dose and multiple dose cohort study of orally administered Norketotifen (NKT) in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Norketotifen Oral Capsule (Cohort 1), Norketotifen Oral Capsule (Cohort 2) and Norketotifen Oral Capsule (Cohort 3)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 14 Mar 2019
- 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
- Body mass index (BMI) of 18 to 30 kg/m^2
- Negative serum pregnancy test (females); females of childbearing potential and males must agree to use acceptable contraception
Who cannot join
- Pregnant or lactating (females)
- Clinically significant past or current medical or surgical history
- Clinically significant illness or abnormality on physical examination, 12-lead ECG, laboratory values
- Participation in an investigational drug or device study within 30 days prior to Screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, 2-Part, Single Ascending Dose and Multiple Dose Cohort Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Norketotifen in Healthy Subjects
This is a Phase 1, single-center, double-blind, randomized, placebo-controlled, 2-part, single ascending dose and multiple dose cohort study of orally administered Norketotifen (NKT) in healthy subjects.
Read the detailed description
Single Ascending Dose: Three single ascending dose cohorts are planned. A total of 10 subjects will be enrolled in each cohort and will be randomly assigned to receive a single oral dose of NKT (n=8) or a matching placebo (n=2). A Safety Review Team (SRT) will review all available safety data in a blinded manner following the completion of each cohort to determine the next dose level to be evaluated in the next cohort.
Multiple Dose Cohort: A total of 10 subjects will be enrolled and will be randomly assigned to receive multiple oral doses of NKT (n=8) or a matching placebo (n=2) once daily for an adequate number of days to reach steady state (the number of days will be determined based on the half-life of NKT in Part A). The dose of NKT to be evaluated will be determined by the SRT.
- Conditions
- Healthy Subjects
- Being tested
- Norketotifen Oral Capsule (Cohort 1), Norketotifen Oral Capsule (Cohort 2), Norketotifen Oral Capsule (Cohort 3), Norketotifen Oral Capsule (Multiple Dose Cohort), Placebo Oral Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norketotifen Oral Capsule (Cohort 1)Drug
Single dose Norketotifen
Norketotifen Oral Capsule (Cohort 2)Drug
Single dose Norketotifen
Norketotifen Oral Capsule (Cohort 3)Drug
Single dose Norketotifen
Norketotifen Oral Capsule (Multiple Dose Cohort)Drug
Multiple dose Norketotifen
Placebo Oral CapsuleDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Norketotifen or Placebo (Cohort 1) | Experimental | Not described Receives: Drug: Norketotifen Oral Capsule (Cohort 1); Drug: Placebo Oral Capsule |
| Norketotifen or Placebo (Cohort 2) | Experimental | Not described Receives: Drug: Norketotifen Oral Capsule (Cohort 2); Drug: Placebo Oral Capsule |
| Norketotifen or Placebo (Cohort 3) | Experimental | Not described Receives: Drug: Norketotifen Oral Capsule (Cohort 3); Drug: Placebo Oral Capsule |
| Norketotifen or Placebo (Multiple Dose) | Experimental | Not described Receives: Drug: Norketotifen Oral Capsule (Multiple Dose Cohort); Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events following single doses
Including clinically significant and Grade 3 abnormalities in laboratory values, vital signs, ECGs, and physical examination
Measured: Through Day 4
Number of subjects with adverse events following multiple doses
Including clinically significant and Grade 3 abnormalities in laboratory values, vital signs, ECGs, and physical examination
Measured: Through Day 7
Secondary outcomes (12)
Maximum plasma concentration (Cmax) following single doses
Measured: Through Day 4
Maximum plasma concentration (Cmax) following multiple doses
Measured: Through Day 7
Time to maximum concentration (Tmax) following single doses
Measured: Through Day 4
Time to maximum concentration (Tmax) following multiple doses
Measured: Through Day 7
Area under the plasma concentration time curve (AUC) following single doses
Measured: Through Day 4
Area under the plasma concentration time curve (AUC) following multiple doses
Measured: Through Day 7
Elimination half-life (t1/2) following single doses
Measured: Through Day 4
Elimination half-life (t1/2) following multiple doses
Measured: Through Day 7
Apparent clearance (CL/F) following single doses
Measured: Through Day 4
Apparent clearance (CL/F) following multiple doses
Measured: Through Day 7
Apparent volume of distribution (Vz/F) following single doses
Measured: Through Day 4
Apparent volume of distribution (Vz/F) following multiple doses
Measured: Through Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start15 Oct 2018
- Primary completion18 Feb 2019
- Study completion14 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergo Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cynthia Zamora, MD, Principal investigator, Worldwide Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712163
- Sponsor's protocol ID
- NKT-101
- Status last verified
- Mar 2019
- First submitted
- 12 Oct 2018
- Last updated
- 21 Mar 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, 2-Part, Single Ascending Dose and Multiple Dose Cohort Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Norketotifen in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03712163
- Acronym / sponsor ID
- NKT-101
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Emergo Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 18 Feb 2019 (actual)
- Study completion
- 14 Mar 2019 (actual)
- First posted
- 19 Oct 2018 (actual)
- 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, single-center, double-blind, randomized, placebo-controlled, 2-part, single ascending dose and multiple dose cohort study of orally administered Norketotifen (NKT) in healthy subjects.
Detailed description
Single Ascending Dose: Three single ascending dose cohorts are planned. A total of 10 subjects will be enrolled in each cohort and will be randomly assigned to receive a single oral dose of NKT (n=8) or a matching placebo (n=2). A Safety Review Team (SRT) will review all available safety data in a blinded manner following the completion of each cohort to determine the next dose level to be evaluated in the next cohort.
Multiple Dose Cohort: A total of 10 subjects will be enrolled and will be randomly assigned to receive multiple oral doses of NKT (n=8) or a matching placebo (n=2) once daily for an adequate number of days to reach steady state (the number of days will be determined based on the half-life of NKT in Part A). The dose of NKT to be evaluated will be determined by the SRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Norketotifen or Placebo (Cohort 1) | Experimental | Drug: Norketotifen Oral Capsule (Cohort 1), Drug: Placebo Oral Capsule |
| Norketotifen or Placebo (Cohort 2) | Experimental | Drug: Norketotifen Oral Capsule (Cohort 2), Drug: Placebo Oral Capsule |
| Norketotifen or Placebo (Cohort 3) | Experimental | Drug: Norketotifen Oral Capsule (Cohort 3), Drug: Placebo Oral Capsule |
| Norketotifen or Placebo (Multiple Dose) | Experimental | Drug: Norketotifen Oral Capsule (Multiple Dose Cohort), Drug: Placebo Oral Capsule |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) of 18 to 30 kg/m^2
- Negative serum pregnancy test (females); females of childbearing potential and males must agree to use acceptable contraception
Key exclusion criteria (4 listed)
- Pregnant or lactating (females)
- Clinically significant past or current medical or surgical history
- Clinically significant illness or abnormality on physical examination, 12-lead ECG, laboratory values
- Participation in an investigational drug or device study within 30 days prior to Screening
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 |
|---|---|---|
| Norketotifen Oral Capsule (Cohort 1)Single dose Norketotifen | Drug | Norketotifen or Placebo (Cohort 1) |
| Norketotifen Oral Capsule (Cohort 2)Single dose Norketotifen | Drug | Norketotifen or Placebo (Cohort 2) |
| Norketotifen Oral Capsule (Cohort 3)Single dose Norketotifen | Drug | Norketotifen or Placebo (Cohort 3) |
| Norketotifen Oral Capsule (Multiple Dose Cohort)Multiple dose Norketotifen | Drug | Norketotifen or Placebo (Multiple Dose) |
| Placebo Oral CapsulePlacebo | Drug | Norketotifen or Placebo (Cohort 1), Norketotifen or Placebo (Cohort 2), Norketotifen or Placebo (Cohort 3), Norketotifen or Placebo (Multiple Dose) |
Primary outcome
Number of subjects with adverse events following single doses
Time frame: Through Day 4
Including clinically significant and Grade 3 abnormalities in laboratory values, vital signs, ECGs, and physical examination
Number of subjects with adverse events following multiple doses
Time frame: Through Day 7
Including clinically significant and Grade 3 abnormalities in laboratory values, vital signs, ECGs, and physical examination
12 secondary outcomes
Maximum plasma concentration (Cmax) following single doses
Time frame: Through Day 4
Maximum plasma concentration (Cmax) following multiple doses
Time frame: Through Day 7
Time to maximum concentration (Tmax) following single doses
Time frame: Through Day 4
Time to maximum concentration (Tmax) following multiple doses
Time frame: Through Day 7
Area under the plasma concentration time curve (AUC) following single doses
Time frame: Through Day 4
Area under the plasma concentration time curve (AUC) following multiple doses
Time frame: Through Day 7
Elimination half-life (t1/2) following single doses
Time frame: Through Day 4
Elimination half-life (t1/2) following multiple doses
Time frame: Through Day 7
Apparent clearance (CL/F) following single doses
Time frame: Through Day 4
Apparent clearance (CL/F) following multiple doses
Time frame: Through Day 7
Apparent volume of distribution (Vz/F) following single doses
Time frame: Through Day 4
Apparent volume of distribution (Vz/F) following multiple doses
Time frame: Through Day 7
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 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Cynthia Zamora, MD principal investigator
Worldwide Clinical Trials
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 Norketotifen Oral Capsule (Cohort 1), Norketotifen Oral Capsule (Cohort 2) and Norketotifen Oral Capsule (Cohort 3) in people with Healthy Subjects, run by Emergo 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 2 inclusion and 4 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 Mar 2019. 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. 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?
Number of subjects with adverse events following single doses (time frame: Through Day 4). The study lists 2 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 Mar 2019.