Long QT SyndromePhase 1NCT05759962
Phase 1 Study of LQT-1213 in Healthy Adults
A Phase 1 study testing LQT-1213 in people with Long QT Syndrome, run by Thryv Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a single-center, randomized, double-blind, placebo-controlled study to be conducted in 2 parts: single ascending dose (SAD) incorporating a food effect arm and multiple ascending dose (MAD). Potential participants for each part will undergo screening procedures within 28 days of enrollment. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Long QT Syndrome
- What is being tested?
- LQT-1213
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2022to 5 Mar 2023
- 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
- Healthy adult male or female participants
- Females of childbearing potential must agree and commit to use an adequate form of contraception.
- Men who are biologically capable of fathering children must agree and commit to use an adequate form of contraception.
- Aged at least 18 years but not older than 60 years (inclusive)
- Body mass index (BMI) within 18.0 kg/m^2 to 32.0 kg/m^2, inclusively.
- Non- or ex-smoker
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator.
Who cannot join
- Clinically significant diseases or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study results.
- Clinically significant abnormal findings on the physical examination or medical history during screening as deemed by the principal investigator
- Female who is lactating
- Female who is pregnant
- Male participants with a history of oligospermia or azoospermia or any other disorder of the reproductive system
- Male participants who are undergoing treatment or evaluation for infertility.
Show all 10Show fewer
- History of significant hypersensitivity to LQT-1213, kinase inhibitors or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Use of immunosuppressant in the 28 days prior to the first study drug administration
- Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- Intake of an investigational product or participation in a clinical trial in the 90 days prior to the first study drug administration
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Los Angeles, Inc.
Cypress, California, 90630
About this study
Official title: A Phase 1, Randomized, Double-blinded, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluated the Safety, Tolerability, Pharmacokinetics, Food Effect, and Pharmacodynamics of LQT-1213 in Healthy Adult Participants
This is a single-center, randomized, double-blind, placebo-controlled study to be conducted in 2 parts: single ascending dose (SAD) incorporating a food effect arm and multiple ascending dose (MAD). Potential participants for each part will undergo screening procedures within 28 days of enrollment.
- Conditions
- Long QT Syndrome
- Being tested
- LQT-1213, Placebo
- Keywords
- LQT-1213, Congenital Long QT Syndrome, LQTS, Serum glucocorticoid regulated kinase-1, SGK-1 inhibitor
- Medical subject headings
- Long QT Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LQT-1213Drug
LQT-1213 is a serum glucocorticoid regulated kinase 1 (SGK-1) inhibitor
PlaceboOther
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single Ascending Dose (SAD) LQT-1213 | Experimental | In Part A, 4 dosing cohorts will receive a single oral dose of LQT-1213. The highest dose of LQT-1213 to be administered is 1.67 mg/kg. Receives: Drug: LQT-1213 |
| Part A: Food Effect LQT-1213 | Experimental | In Part A, food effect will be integrated into one of the SAD cohorts as a single dose, two-period with at least a 7-day washout, crossover cohort. Receives: Drug: LQT-1213 |
| Part B: Multiple Ascending Dose (MAD) LQT-1213 | Experimental | In Part B, 3 dosing cohorts will receive LQT-1213 in the morning on Day 1 and Day 7 and twice daily (BID) on Days 2 to 6. Receives: Drug: LQT-1213 |
| Part A: Single Ascending Dose (SAD) Placebo | Placebo comparator | In Part A, 6 dosing cohorts will receive a single oral dose of placebo. Receives: Other: Placebo |
| Part A: Food Effect Placebo | Placebo comparator | In Part A, food effect will be integrated into one of the SAD cohorts as a single dose, two-period with at least a 7-day washout, crossover cohort. Receives: Other: Placebo |
| Part B: Multiple Ascending Dose (MAD) Placebo | Placebo comparator | In Part B, 3 dosing cohorts will receive placebo in the morning on Day 1 and Day 7 and twice daily (BID) on Days 2 to 6. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability: Number of Participants with Adverse Events
Number of Participants with Adverse Events
Measured: Part A SAD: Day 7; Part A Food Effect: Day 15; Part B MAD: Day 16
Secondary outcomes (19)
Plasma Pharmacokinetics of LQT-1213: Tlag
Initial plasma concentration lag time
Measured: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8
Plasma Pharmacokinetics of LQT-1213: Cmax
Maximum observed plasma drug concentration
Measured: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1 and 7
Plasma Pharmacokinetics of LQT-1213: Tmax
Time to maximum observed plasma drug concentration
Measured: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1
Plasma Pharmacokinetics of LQT-1213: T1/2
Terminal phase half-life
Measured: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1 and 7
Plasma Pharmacokinetics of LQT-1213: AUC0-12, AUC0-T, and AUC0-∞=
Area under the plasma drug concentration versus time curve
Measured: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1
Plasma Pharmacokinetics of LQT-1213: CL/F
Clearance, parent only
Measured: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1
Plasma Pharmacokinetics of LQT-1213: Vz/F
Volume of distribution, parent only
Measured: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1
Plasma Pharmacokinetics of LQT-1213: λz
Terminal elimination rate constant
Measured: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8
Urine Pharmacokinetics of LQT-1213: Ae
Amount of the administered dose recovered over the entire 24-hour interval
Measured: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Urine Pharmacokinetics of LQT-1213: Ae0-t
Amount excreted unchanged in urine over a given time interval
Measured: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Urine Pharmacokinetics of LQT-1213: Fe
Percentage of the administered dose recovered over the entire 24-hour interval
Measured: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Urine Pharmacokinetics of LQT-1213: Fe/F
Fraction of dose excreted in urine
Measured: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Urine Pharmacokinetics of LQT-1213: CLR
Renal clearance Ae0-t/AUC0-t
Measured: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Plasma Pharmacokinetics of LQT-1213: Ctrough
Concentration of drug in the blood immediately before the next dose is administered
Measured: Part B MAD: Days 3-6
Plasma Pharmacokinetics of LQT-1213: Cmin
Minimum observed plasma drug concentration
Measured: Part B MAD: Day 7
Plasma Pharmacokinetics of LQT-1213: AUC0-tau, AUC0-T, and AUC0-∞
Area under the plasma drug concentration versus time curve
Measured: Part B MAD: Day 7
Plasma Pharmacokinetics of LQT-1213: CL/Fss
Clearance, parent only
Measured: Part B MAD: Day 7
Plasma Pharmacokinetics of LQT-1213: Vz/Fss
Volume of Distribution, parent only
Measured: Part B MAD: Day 7
Plasma Pharmacokinetics of LQT-1213: Rac(AUC) and Rac(Cmax)
Drug accumulation ratio
Measured: Part B MAD: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start14 Sep 2022
- Primary completion5 Mar 2023
- Study completion5 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long QT SyndromeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thryv Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759962
- Sponsor's protocol ID
- LQT-1213-0059
- Status last verified
- Sep 2023
- First submitted
- 4 Jan 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blinded, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluated the Safety, Tolerability, Pharmacokinetics, Food Effect, and Pharmacodynamics of LQT-1213 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05759962
- Acronym / sponsor ID
- LQT-1213-0059
- Conditions
- Long QT Syndrome
- Keywords
- LQT-1213, Congenital Long QT Syndrome, LQTS, Serum glucocorticoid regulated kinase-1, SGK-1 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Thryv Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 5 Mar 2023 (actual)
- Study completion
- 5 Mar 2023 (actual)
- First posted
- 8 Mar 2023 (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 single-center, randomized, double-blind, placebo-controlled study to be conducted in 2 parts: single ascending dose (SAD) incorporating a food effect arm and multiple ascending dose (MAD). Potential participants for each part will undergo screening procedures within 28 days of enrollment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A: Single Ascending Dose (SAD) LQT-1213 | Experimental | Drug: LQT-1213In Part A, 4 dosing cohorts will receive a single oral dose of LQT-1213. The highest dose of LQT-1213 to be administered is 1.67 mg/kg. |
| Part A: Food Effect LQT-1213 | Experimental | Drug: LQT-1213In Part A, food effect will be integrated into one of the SAD cohorts as a single dose, two-period with at least a 7-day washout, crossover cohort. |
| Part B: Multiple Ascending Dose (MAD) LQT-1213 | Experimental | Drug: LQT-1213In Part B, 3 dosing cohorts will receive LQT-1213 in the morning on Day 1 and Day 7 and twice daily (BID) on Days 2 to 6. |
| Part A: Single Ascending Dose (SAD) Placebo | Placebo comparator | Other: PlaceboIn Part A, 6 dosing cohorts will receive a single oral dose of placebo. |
| Part A: Food Effect Placebo | Placebo comparator | Other: PlaceboIn Part A, food effect will be integrated into one of the SAD cohorts as a single dose, two-period with at least a 7-day washout, crossover cohort. |
| Part B: Multiple Ascending Dose (MAD) Placebo | Placebo comparator | Other: PlaceboIn Part B, 3 dosing cohorts will receive placebo in the morning on Day 1 and Day 7 and twice daily (BID) on Days 2 to 6. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adult male or female participants
- Females of childbearing potential must agree and commit to use an adequate form of contraception.
- Men who are biologically capable of fathering children must agree and commit to use an adequate form of contraception.
- Aged at least 18 years but not older than 60 years (inclusive)
- Body mass index (BMI) within 18.0 kg/m^2 to 32.0 kg/m^2, inclusively.
Key exclusion criteria (10 listed)
- Clinically significant diseases or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study results.
- Clinically significant abnormal findings on the physical examination or medical history during screening as deemed by the principal investigator
- Female who is lactating
- Female who is pregnant
- Male participants with a history of oligospermia or azoospermia or any other disorder of the reproductive system
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 |
|---|---|---|
| LQT-1213LQT-1213 is a serum glucocorticoid regulated kinase 1 (SGK-1) inhibitor | Drug | Part A: Food Effect LQT-1213, Part A: Single Ascending Dose (SAD) LQT-1213, Part B: Multiple Ascending Dose (MAD) LQT-1213 |
| PlaceboMatching Placebo | Other | Part A: Food Effect Placebo, Part A: Single Ascending Dose (SAD) Placebo, Part B: Multiple Ascending Dose (MAD) Placebo |
Primary outcome
Safety and Tolerability: Number of Participants with Adverse Events
Time frame: Part A SAD: Day 7; Part A Food Effect: Day 15; Part B MAD: Day 16
Number of Participants with Adverse Events
19 secondary outcomes
Plasma Pharmacokinetics of LQT-1213: Tlag
Time frame: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8
Plasma Pharmacokinetics of LQT-1213: Cmax
Time frame: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1 and 7
Plasma Pharmacokinetics of LQT-1213: Tmax
Time frame: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1
Plasma Pharmacokinetics of LQT-1213: T1/2
Time frame: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1 and 7
Plasma Pharmacokinetics of LQT-1213: AUC0-12, AUC0-T, and AUC0-∞=
Time frame: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1
Plasma Pharmacokinetics of LQT-1213: CL/F
Time frame: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1
Plasma Pharmacokinetics of LQT-1213: Vz/F
Time frame: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1
Plasma Pharmacokinetics of LQT-1213: λz
Time frame: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8
Urine Pharmacokinetics of LQT-1213: Ae
Time frame: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Urine Pharmacokinetics of LQT-1213: Ae0-t
Time frame: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Urine Pharmacokinetics of LQT-1213: Fe
Time frame: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Urine Pharmacokinetics of LQT-1213: Fe/F
Time frame: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Urine Pharmacokinetics of LQT-1213: CLR
Time frame: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Plasma Pharmacokinetics of LQT-1213: Ctrough
Time frame: Part B MAD: Days 3-6
Plasma Pharmacokinetics of LQT-1213: Cmin
Time frame: Part B MAD: Day 7
Plasma Pharmacokinetics of LQT-1213: AUC0-tau, AUC0-T, and AUC0-∞
Time frame: Part B MAD: Day 7
Plasma Pharmacokinetics of LQT-1213: CL/Fss
Time frame: Part B MAD: Day 7
Plasma Pharmacokinetics of LQT-1213: Vz/Fss
Time frame: Part B MAD: Day 7
Plasma Pharmacokinetics of LQT-1213: Rac(AUC) and Rac(Cmax)
Time frame: Part B MAD: 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 26 Sep 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 LQT-1213 in people with Long QT Syndrome, run by Thryv 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 7 inclusion and 10 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 26 Sep 2023. 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?
Safety and Tolerability: Number of Participants with Adverse Events (time frame: Part A SAD: Day 7; Part A Food Effect: Day 15; Part B MAD: Day 16). 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 26 Sep 2023.