A Phase 1 Trial of LIB-01 in Healthy Participants.

May 29, 2024 updated by: Dicot AB

A Phase 1, Randomized, Double-blind, Parallel and Placebo-controlled Single and Multiple Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of LIB-01 in Healthy Participants.

The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetics of LIB-01 in healthy male participants. The main questions it aims to answer are:

  • How safe and tolerable is LIB-01 when given once or repeatedly at different dose levels.
  • What are the pharmacokinetic characteristics of LIB-01

Participants will receive LIB-01 and be followed up for safety and pharmacokinetics by:

  • Adverse events
  • ECG
  • Blood sampling for laboratory parameters and pharmacokinetic analysis

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: C Gauffin
  • Phone Number: +46703000592
  • Email: info@dicot.se

Study Locations

  • Sweden
      • Uppsala, Sweden, 75237
        • Clinical Trial Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  1. Provision of signed and dated written informed consent prior to any trial specific procedures.
  2. Healthy male participant aged 18 to 65 years, inclusive.
  3. Body mass index ≥ 18.5 and ≤ 30.0 kg/m2.
  4. Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values.
  5. Participants must be willing to use an acceptable form of contraception and refrain from donating sperm from the administration of IMP until 3 months after the administration of IMP. Any female partner of a non-vasectomised male participant who is of child-bearing potential must use an acceptable contraceptive method from at least 2 weeks prior to the administration of IMP to 4 weeks after the administration of IMP.
  6. Understands the trial requirements.
  7. MAD participants only: Mild to moderate erectile dysfunction.

Exclusion criteria

  1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.
  2. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the (first) administration of IMP.
  3. Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
  4. Any planned major surgery within the duration of the trial.
  5. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to LIB-01.
  6. History of priapism.
  7. History of glaucoma.
  8. History of Non-Arteritic Anterior Ischemic Optic Neuropathy.
  9. History of prostatectomy or prostate surgery.
  10. Bleeding deficiencies or ongoing anticoagulant therapy that would put the participant at risk.
  11. Cardiac disease, including but not limited to uncontrolled hypertension; unstable angina; myocardial infarction or cerebrovascular accident.
  12. Any positive result for serum hepatitis B surface antigen, hepatitis C antibodies and/or human immunodeficiency virus (HIV).
  13. Abnormal vital signs.
  14. Shortened QT interval corrected according to Fridericia (QTcF), prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant ECG abnormalities.
  15. Use of oral, injectable, or topical pro-erectile drugs or supplements.
  16. Use of nitrates.
  17. Ongoing antiandrogen treatment.
  18. Regular use of any prescribed or non-prescribed medications, within 2 weeks (Part I:SAD) or 4 weeks (Part II: MAD) prior to the (first) administration of IMP, except occasional intake of paracetamol, as well as nasal decongestants without cortisone, antihistamine or anticholinergics for a maximum of 10 days.
  19. Planned treatment or treatment with another investigational drug.
  20. Current smokers or users of nicotine products.
  21. Positive screening result for drugs of abuse or alcohol.
  22. History of alcohol abuse or excessive intake of alcohol.
  23. Presence or history of drug abuse.
  24. History of, or current use of anabolic steroids.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LIB-01
LIB-01 oral suspension
Drug: LIB-01
LIB-01 oral suspension
Placebo Comparator: Placebo
Placebo oral suspension
Other: Placebo
Placebo oral suspension

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following a single oral dose of LIB-01.
Time Frame: 14 days

Frequency, seriousness and intensity of adverse events. Adverse events will be graded from 1-5 by the Common Terminology Criteria for Adverse Events (CTCAE):

Grade 1, Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.

Grade 2, Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL).

Grade 3, Severe or medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self- care ADL.

Grade 4, Life-threatening consequences: urgent intervention indicated. Grade 5, Death related to AE.
14 days
To evaluate changes in vital signs in healthy male participants, following a single oral dose of LIB-01.
Time Frame: 14 days
Clinically significant changes in vital signs (blood pressure, pulse, respiratory rate, body temperature).
14 days
To evaluate changes in ECG in healthy male participants, following a single oral dose of LIB-01.
Time Frame: 14 days
Clinically significant changes in ECG parameters (resting heart rate [HR] and PQ/PR, QRS, QT and QTcF intervals).
14 days
To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following multiple oral dosing of LIB-01.
Time Frame: 28 days

Frequency, seriousness and intensity of adverse events. Adverse events will be graded from 1-5 by the Common Terminology Criteria for Adverse Events (CTCAE):

Grade 1, Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.

Grade 2, Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL).

Grade 3, Severe or medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self- care ADL.

Grade 4, Life-threatening consequences: urgent intervention indicated. Grade 5, Death related to AE. Clinically significant changes in vital signs, ECG and safety laboratory measurements.
28 days
To evaluate changes in vital signs in healthy male participants, following a multiple oral dosing of LIB-01.
Time Frame: 28 days
Clinically significant changes in vital signs (blood pressure, pulse, respiratory rate, body temperature).
28 days
To evaluate changes in ECG in healthy male participants, following multiple oral dosing of LIB-01.
Time Frame: 28 days
Clinically significant changes in ECG parameters (resting heart rate [HR] and PQ/PR, QRS, QT and QTcF intervals).
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To characterise the maximum plasma concentration of LIB-01, following a single oral dose.
Time Frame: 3 days
Maximum Plasma Concentration [Cmax]
3 days
To characterise the plasma concentration half life of LIB-01, following a single oral dose.
Time Frame: 3 days
Plasma Concentration Half Life [T1/2]
3 days
To characterise the plasma concentration area under curve of LIB-01, following a single oral dose.
Time Frame: 3 days
Plasma Concentration Area Under Curve [AUC]
3 days
To characterise the maximum plasma concentration of LIB-01 following multiple oral dosing.
Time Frame: 4 days
Maximum Plasma Concentration [Cmax]
4 days
To characterise the plasma concentration half life of LIB-01 following multiple oral dosing.
Time Frame: 4 days
Plasma Concentration Half Life [T1/2]
4 days
To characterise the plasma concentration half life of LIB-01 following multiple oral dosing.
Time Frame: 4 days
Plasma Concentration Area Under Curve [AUC]
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dicot AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Björn Schultze, MD, CTC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DCT3934

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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