Erectile DysfunctionPhase 1NCT06324006
A Phase 1 Trial of LIB-01 in Healthy Participants.
A Phase 1 study testing LIB-01 in people with Erectile Dysfunction, run by Dicot AB at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- LIB-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSweden
- Study dates
- 25 Aug 2023to 29 May 2024
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated written informed consent prior to any trial specific procedures.
- Healthy male participant aged 18 to 65 years, inclusive.
- Body mass index ≥ 18.5 and ≤ 30.0 kg/m2.
- Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values.
- 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.
- Understands the trial requirements.
- MAD participants only: Mild to moderate erectile dysfunction.
Who cannot join
- 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.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the (first) administration of IMP.
- Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the trial.
- 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.
- History of priapism.
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- History of glaucoma.
- History of Non-Arteritic Anterior Ischemic Optic Neuropathy.
- History of prostatectomy or prostate surgery.
- Bleeding deficiencies or ongoing anticoagulant therapy that would put the participant at risk.
- Cardiac disease, including but not limited to uncontrolled hypertension; unstable angina; myocardial infarction or cerebrovascular accident.
- Any positive result for serum hepatitis B surface antigen, hepatitis C antibodies and/or human immunodeficiency virus (HIV).
- Abnormal vital signs.
- Shortened QT interval corrected according to Fridericia (QTcF), prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant ECG abnormalities.
- Use of oral, injectable, or topical pro-erectile drugs or supplements.
- Use of nitrates.
- Ongoing antiandrogen treatment.
- 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.
- Planned treatment or treatment with another investigational drug.
- Current smokers or users of nicotine products.
- Positive screening result for drugs of abuse or alcohol.
- History of alcohol abuse or excessive intake of alcohol.
- Presence or history of drug abuse.
- History of, or current use of anabolic steroids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Erectile Dysfunction
- Being tested
- LIB-01, Placebo
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIB-01Drug
LIB-01 oral suspension
PlaceboOther
Placebo oral suspension
| Study group | Role | What they receive |
|---|---|---|
| LIB-01 | Experimental | LIB-01 oral suspension Receives: Drug: LIB-01 |
| Placebo | Placebo comparator | Placebo oral suspension Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 14 days
To evaluate changes in vital signs in healthy male participants, following a single oral dose of LIB-01.
Clinically significant changes in vital signs (blood pressure, pulse, respiratory rate, body temperature).
Measured: 14 days
To evaluate changes in ECG in healthy male participants, following a single oral dose of LIB-01.
Clinically significant changes in ECG parameters (resting heart rate [HR] and PQ/PR, QRS, QT and QTcF intervals).
Measured: 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.
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.
Measured: 28 days
To evaluate changes in vital signs in healthy male participants, following a multiple oral dosing of LIB-01.
Clinically significant changes in vital signs (blood pressure, pulse, respiratory rate, body temperature).
Measured: 28 days
To evaluate changes in ECG in healthy male participants, following multiple oral dosing of LIB-01.
Clinically significant changes in ECG parameters (resting heart rate [HR] and PQ/PR, QRS, QT and QTcF intervals).
Measured: 28 days
Secondary outcomes (6)
To characterise the maximum plasma concentration of LIB-01, following a single oral dose.
Maximum Plasma Concentration [Cmax]
Measured: 3 days
To characterise the plasma concentration half life of LIB-01, following a single oral dose.
Plasma Concentration Half Life [T1/2]
Measured: 3 days
To characterise the plasma concentration area under curve of LIB-01, following a single oral dose.
Plasma Concentration Area Under Curve [AUC]
Measured: 3 days
To characterise the maximum plasma concentration of LIB-01 following multiple oral dosing.
Maximum Plasma Concentration [Cmax]
Measured: 4 days
To characterise the plasma concentration half life of LIB-01 following multiple oral dosing.
Plasma Concentration Half Life [T1/2]
Measured: 4 days
To characterise the plasma concentration half life of LIB-01 following multiple oral dosing.
Plasma Concentration Area Under Curve [AUC]
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start25 Aug 2023
- Primary completion23 Apr 2024
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies 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
- Parallel groups
- Model description
- This is a Phase I, double-blind, parallel-group, placebo-controlled, randomized first-in-human trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dicot AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Björn Schultze, MD, Principal investigator, CTC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324006
- Sponsor's protocol ID
- DCT3934
- Status last verified
- May 2024
- First submitted
- 20 Sep 2023
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06324006
- Acronym / sponsor ID
- DCT3934
- Conditions
- Erectile Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Dicot ABIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 21 Mar 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a Phase I, double-blind, parallel-group, placebo-controlled, randomized first-in-human trial.
| Arm | Type | Receives |
|---|---|---|
| LIB-01 | Experimental | Drug: LIB-01LIB-01 oral suspension |
| Placebo | Placebo comparator | Other: PlaceboPlacebo oral suspension |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of signed and dated written informed consent prior to any trial specific procedures.
- Healthy male participant aged 18 to 65 years, inclusive.
- Body mass index ≥ 18.5 and ≤ 30.0 kg/m2.
- Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values.
- 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.
Key exclusion criteria (24 listed)
- 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.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the (first) administration of IMP.
- Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the trial.
- 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.
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 |
|---|---|---|
| LIB-01LIB-01 oral suspension | Drug | LIB-01 |
| PlaceboPlacebo oral suspension | Other | Placebo |
Primary outcome
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.
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).
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).
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.
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).
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).
6 secondary outcomes
To characterise the maximum plasma concentration of LIB-01, following a single oral dose.
Time frame: 3 days
To characterise the plasma concentration half life of LIB-01, following a single oral dose.
Time frame: 3 days
To characterise the plasma concentration area under curve of LIB-01, following a single oral dose.
Time frame: 3 days
To characterise the maximum plasma concentration of LIB-01 following multiple oral dosing.
Time frame: 4 days
To characterise the plasma concentration half life of LIB-01 following multiple oral dosing.
Time frame: 4 days
To characterise the plasma concentration half life of LIB-01 following multiple oral dosing.
Time frame: 4 days
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 30 May 2024.
- 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.
Björn Schultze, MD principal investigator
CTC
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 LIB-01 in people with Erectile Dysfunction, run by Dicot AB at 1 site in Sweden.
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 24 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 30 May 2024. 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 Sweden. 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?
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). The study lists 6 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 30 May 2024.