AnalgesiaPhase 1NCT03880487
A Single and Multiple Ascending Dose Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of KP-1199
A Phase 1 study testing KP-1199 and Oxycodone oral capsule in people with Analgesia, run by Kalyra Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a Phase I, randomized, placebo and active-controlled, double blind, single and multiple ascending dose study in healthy adults to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of KP-1199 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- KP-1199 and Oxycodone oral capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2019to 21 Apr 2020
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Adult 18-45 years of age at time of screening, inclusive.
- Have a body mass index (BMI) between 18.0 and ≤32 kg/m2, inclusive, and a weight of ≥50 kg at screening.
- Be determined to be healthy on the basis of a pre-study physical examination, medical history review, vital sign measurements, and the results of laboratory tests.
- For both male and females: using acceptable method of birth control
- If Female: not-pregnant or not breast feeding and not planning on becoming pregnant
- All prescribed medication must have been stopped at least 14 days prior to admission to the clinical research site. An exception is made for hormonal contraceptives, which may be used throughout the study.
- All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior to admission to the clinical research site.
- Must be adequately informed and understand the nature and risks of the study and must provide written informed consent prior to enrollment at screening.
Who cannot join
- Subjects who participate in one part of the study are not eligible to participate in subsequent parts of the study.
- Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
- Males with female partners who are planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
- History or evidence of significant clinical or psychiatric disorder, condition, or disease that, in the opinion of the Investigator would pose an unacceptable risk to the subject safety or interfere with the study evaluations, procedures, or completion of the study.
- Documented congenital QT syndrome, and/or corrected QT interval (Fridericia correction; QTcF) at screening or first admission > 450 ms.
- Positive screening test for hepatitis B surface antigen, anti-hepatitis C virus antibodies or anti-human immunodeficiency virus 1 and 2 antibodies.
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- History of drug allergy diagnosed by a physician.
- Use of tobacco within 30 days prior to the first study drug administration.
- History of alcohol consumption exceeding 2 standard drinks per day on average.
- Routine or chronic use of more than 0.5 grams of acetaminophen daily.
- History of donation of more than 450 mL of blood within 60 days prior to dosing in the clinical research site or planned donation before 30 days has elapsed since intake of study drug.
- Plasma or platelet donation within 7 days of dosing
- Use of any investigational drug or device within 30 days of the first dose of study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo- and Active-Controlled, Double-Blind, Single and Multiple Ascending Dose Study in Healthy Adults to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KP-1199
This is a Phase I, randomized, placebo and active-controlled, double blind, single and multiple ascending dose study in healthy adults to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of KP-1199
- Conditions
- Analgesia
- Being tested
- KP-1199, Placebo oral capsule, Oxycodone oral capsule
- Keywords
- Phase I, Healthy Adult Participants
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KP-1199Drug
Single dose and Multiple ascending doses of KP-1199 oral capsules
Placebo oral capsuleDrug
Single dose and Multiple dose identical to active treatment but without KP-1199.
Oxycodone oral capsuleDrug
10 mg Oxycodone Capsules
| Study group | Role | What they receive |
|---|---|---|
| KP-1199 | Experimental | Not described Receives: Drug: KP-1199 |
| Placebo oral capsules | Placebo comparator | Not described Receives: Drug: Placebo oral capsule |
| Oxycodone oral capsules | Active comparator | Not described Receives: Drug: Oxycodone oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events
Number of treatment related adverse events as determined by abnormal clinical laboratory tests, vitals signs, physical exam, ECG parameters
Measured: Part 1: From Day 1 through Day 6, Part 2: From Day 1 through Day 11, Part 3: From Day 1 through Day 12
Secondary outcomes (9)
Pharmacokinetic Profile of KP-1199 to measure plasma concentration of KP-1199
Maximum Observed Plasma Concentration (Cmax)
Measured: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
Pharmacokinetic Profile of KP-1199 to measure Time to Maximum plasma concentration of KP-1199
Time to Maximum Plasma Concentration (Tmax)
Measured: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
Pharmacokinetic Profile of KP-1199 to measure area under curve plasma concentration of KP-1199
Area Under the Concentration-time Curve Up to Time (t), where t is the last point with concentrations above the lower limit of quantitation (AUC0-t) Area Under the Concentration-time Curve for 1 dosing interval of a multiple dose regimen (AUCtau)
Measured: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
Pharmacokinetic Profile of KP-1199 to measure plasma terminal half-life concentration of KP-1199
The Apparent Terminal Elimination Half-life (t1/2)
Measured: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
Pharmacokinetic Profile of KP-1199 to measure the trough plasma concentration of KP-1199
Trough Plasma Concentration (Ctrough)
Measured: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
Pharmacodynamic Effects of KP-1199 using Cold Pressor Test to measure pain threshold
Time to feel first pain ("pain threshold" measured in seconds)
Measured: Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration)
Pharmacodynamic Effects of KP-1199 using Cold Pressor Test to measure pain tolerance
Time to withdrawal of hand from cold water ("Pain tolerance" in seconds)
Measured: Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration)
Pharmacodynamic Effects of KP-1199 using Cold Pressor Test
Pain tolerance will be measured at time of hand withdrawal using a 11-point (0-10) Numeric Pain Rating Scale (NPRS) where "0 (no pain) to 10 (worst pain)"
Measured: Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration)
Pharmacodynamic Effects of KP-1199 using Ultraviolet Burn Model (UVB)
Neurosensory Testing (change in neurosensory assessments of the skin at site of ultraviolet burn)
Measured: Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start12 Mar 2019
- Primary completion21 Apr 2020
- Study completion21 Apr 2020
Why it stopped: The Study was terminated early by sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kalyra Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Kevin Bunker, PhD, Study director, Kalyra Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880487
- Sponsor's protocol ID
- KP-1199-CP-001
- Other IDs
- CDMRP-OR 160158
- Status last verified
- Feb 2021
- First submitted
- 5 Mar 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo- and Active-Controlled, Double-Blind, Single and Multiple Ascending Dose Study in Healthy Adults to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KP-1199
- ClinicalTrials.gov ID
- NCT03880487
- Acronym / sponsor ID
- KP-1199-CP-001
- Conditions
- Analgesia
- Keywords
- Phase I, Healthy Adult Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Study was terminated early by sponsor
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Kalyra Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, PRA Health Sciences
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 21 Apr 2020 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 19 Mar 2019 (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 I, randomized, placebo and active-controlled, double blind, single and multiple ascending dose study in healthy adults to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of KP-1199
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KP-1199 | Experimental | Drug: KP-1199 |
| Placebo oral capsules | Placebo comparator | Drug: Placebo oral capsule |
| Oxycodone oral capsules | Active comparator | Drug: Oxycodone oral capsule |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy Adult 18-45 years of age at time of screening, inclusive.
- Have a body mass index (BMI) between 18.0 and ≤32 kg/m2, inclusive, and a weight of ≥50 kg at screening.
- Be determined to be healthy on the basis of a pre-study physical examination, medical history review, vital sign measurements, and the results of laboratory tests.
- For both male and females: using acceptable method of birth control
- If Female: not-pregnant or not breast feeding and not planning on becoming pregnant
Key exclusion criteria (13 listed)
- Subjects who participate in one part of the study are not eligible to participate in subsequent parts of the study.
- Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
- Males with female partners who are planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
- History or evidence of significant clinical or psychiatric disorder, condition, or disease that, in the opinion of the Investigator would pose an unacceptable risk to the subject safety or interfere with the study evaluations, procedures, or completion of the study.
- Documented congenital QT syndrome, and/or corrected QT interval (Fridericia correction; QTcF) at screening or first admission > 450 ms.
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 |
|---|---|---|
| KP-1199Single dose and Multiple ascending doses of KP-1199 oral capsules | Drug | KP-1199 |
| Placebo oral capsuleSingle dose and Multiple dose identical to active treatment but without KP-1199. | Drug | Placebo oral capsules |
| Oxycodone oral capsule10 mg Oxycodone Capsules | Drug | Oxycodone oral capsules |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events
Time frame: Part 1: From Day 1 through Day 6, Part 2: From Day 1 through Day 11, Part 3: From Day 1 through Day 12
Number of treatment related adverse events as determined by abnormal clinical laboratory tests, vitals signs, physical exam, ECG parameters
9 secondary outcomes
Pharmacokinetic Profile of KP-1199 to measure plasma concentration of KP-1199
Time frame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
Pharmacokinetic Profile of KP-1199 to measure Time to Maximum plasma concentration of KP-1199
Time frame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
Pharmacokinetic Profile of KP-1199 to measure area under curve plasma concentration of KP-1199
Time frame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
Pharmacokinetic Profile of KP-1199 to measure plasma terminal half-life concentration of KP-1199
Time frame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
Pharmacokinetic Profile of KP-1199 to measure the trough plasma concentration of KP-1199
Time frame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
Pharmacodynamic Effects of KP-1199 using Cold Pressor Test to measure pain threshold
Time frame: Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration)
Pharmacodynamic Effects of KP-1199 using Cold Pressor Test to measure pain tolerance
Time frame: Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration)
Pharmacodynamic Effects of KP-1199 using Cold Pressor Test
Time frame: Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration)
Pharmacodynamic Effects of KP-1199 using Ultraviolet Burn Model (UVB)
Time frame: Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration)
Results and safety
The study was stopped early (reason given: The Study was terminated early by sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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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.
Kevin Bunker, PhD study director
Kalyra Pharmaceuticals, Inc.
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 KP-1199 and Oxycodone oral capsule in people with Analgesia, run by Kalyra Pharmaceuticals, 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 8 inclusion and 13 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: stopped early, as of the sponsor's last update on 16 Sep 2021. 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 was stopped early (reason given: The Study was terminated early by sponsor). Results are not available in the source record.
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 Participants with Treatment Emergent Adverse Events (time frame: Part 1: From Day 1 through Day 6, Part 2: From Day 1 through Day 11, Part 3: From Day 1 through Day 12). 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 16 Sep 2021.