Adverse Effect of Drugs and Medicaments in Therapeutic UsePhase 1NCT05647343

Study to Assess the Safety and Pharmacokinetics of ATL-001 (Ciclopirox Olamine) in Healthy Volunteers

A Phase 1 study testing Ciclopirox Olamine Oral in people with Adverse Effect of Drugs and Medicaments in Therapeutic Use, run by Atlas Molecular Pharma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to assess the safety, tolerability and pharmacokinetics of ATL-001 (ciclopirox olamine) in healthy volunteers Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Adverse Effect of Drugs and Medicaments in Therapeutic Use
What is being tested?: Ciclopirox Olamine Oral
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 42 participants
Where: 1 siteUnited States
Study dates: 31 Mar 2023to 8 Apr 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
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy male or female subjects 18 to 65 years of age, inclusive
Body mass index (BMI) within the range of 18.0 to 33.0 kg/m2, inclusive, and a minimum weight of at least 50.0 and maximum weight of 100.0 kg at Screening
Estimated Glomerular Filtration Rate (eGFR) > 90 mL/min/1.73 m2 at Screening
Female subjects of childbearing potential must be using and willing to continue using two medically acceptable contraceptive precautions from Screening and for at least 1 month after the last study drug administration. Medically acceptable forms of contraception include sexual abstinence [periodic abstinence (e.g., calendar, ovulation, symptothermal and post-ovulation methods) are not acceptable], combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), intrauterine devices (IUD), intrauterine hormone-releasing systems, and bilateral tubal ligation for subjects
Female subjects of non-childbearing potential must be amenorrhoeic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy/salpingo-oophorectomy (as determined by subject medical history)
Male subjects of reproductive potential with a partner(s) of childbearing potential must be using and willing to continue using two medically acceptable contraceptive precautions from Screening and for at least 1 month after the last study drug administration. Medically acceptable forms of contraception include abstinence, vasectomy, or male condom for subjects

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Female subjects must have a negative pregnancy test
Must understand and provide written informed consent prior to the initiation of any protocol-specific procedures
Must be willing and able to abide by all study requirements and restrictions

Who cannot join

Current drug or alcohol dependence (excluding caffeine), based on self-report, including subjects who have been in a drug rehabilitation program
Current smoker or a history of using tobacco products within 3 months prior to Screening
Clinically significant abnormalities on physical examination, medical history, 12-lead ECG (i.e., QTc > 440 ms for male subjects and > 450 ms for female subjects), vital signs, or laboratory values, as judged by the investigator or designee
History or presence of any clinically significant illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other condition, which in the opinion of the investigator would jeopardize the safety of the subject or the validity of the study results
Use of a non-prescription drug within 14 days prior to the first drug administration. Subjects who have taken over-the-counter medication may still be entered into the study, if in the opinion of the investigator or designee, the medication received will not interfere with the study procedures or data integrity or compromise the safety of the subject
Use of any prescription medications, recreational drugs, or natural health products (except vitamin or mineral supplements, acceptable forms of birth control, and hormone replacement) within 14 days prior to first drug administration or throughout the study, unless in the opinion of the investigator or designee, the product will not interfere with the study procedures or data integrity or compromise the safety of the subject

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Use of any medication that interfere with the glucuronidation metabolic pathway within 14 days prior to first drug administration
Positive urine drug screen
Positive breath alcohol test. If a subject presents with positive breath alcohol test, the subject may be rescheduled at the discretion of the investigator or designee
Female subjects who are currently pregnant or lactating or who are planning to become pregnant within 60 days of last study drug administration
Known history of allergy or hypersensitivity to any component of the active drug or placebo
Positive for Hepatitis B, Hepatitis C, HIV or COVID-19
Treatment with any investigational drug within 30 days prior to first drug administration in the treatment phase
A subject who, in the opinion of the investigator or designee, is not considered to be suitable and is unlikely to comply with the study protocol for any reason

Trial locations and contacts

1 site in 1 country.

United States1 site

Hassman Research Institute, LLC
Berlin, New Jersey, 08009

Other trials in United States

About this study

Official title: A Phase I, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety and Pharmacokinetics of ATL-001 (Ciclopirox Olamine) in Healthy Volunteers

The goal of this clinical trial is to assess the safety, tolerability and pharmacokinetics of ATL-001 (ciclopirox olamine) in healthy volunteers

Read the detailed description

Participants will receive either the investigational drug (ATL-001) or Placebo (inactive substance). Neither the participant nor the Investigator will know to which of these study drug groups each participant has been assigned. In case of an emergency, however, the Investigator can get this information.

After a 30-day Screening period to confirm the eligibility, the prticipants will be treated for 5 days (the treatment period) and followed by 30 days of observation and assessment of treatment outcomes (the follow-up period).

Conditions: Adverse Effect of Drugs and Medicaments in Therapeutic Use
Being tested: Ciclopirox Olamine Oral, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ciclopirox Olamine OralDrug
On the morning of Day 1 to Day 5, each participant will receive a single oral dose of ATL-001 or placebo
PlaceboOther
On the morning of Day 1 to Day 5, each participant will receive a single oral dose of ATL-001 or placebo

Study groups in NCT05647343
Study group	Role	What they receive
ATL-001 0.2 mg/kg vs Placebo	Experimental	Cohort 1: ATL-001 at 0.2 mg/kg or Placebo (depending on randomization) will be administered during 5 days Receives: Drug: Ciclopirox Olamine Oral; Other: Placebo
ATL-001 0.5 mg/kg vs Placebo	Experimental	Cohort 2: ATL-001 at 0.5 mg/kg or Placebo (depending on randomization) will be administered during 5 days Receives: Drug: Ciclopirox Olamine Oral; Other: Placebo
ATL-001 1 mg/kg vs Placebo	Experimental	Cohort 3: ATL-001 at 1 mg/kg or Placebo (depending on randomization) will be administered during 5 days Receives: Drug: Ciclopirox Olamine Oral; Other: Placebo
ATL-001 2 mg/kg vs Placebo	Experimental	Cohort 4: ATL-001 at 2 mg/kg or Placebo (depending on randomization) will be administered during 5 days Receives: Drug: Ciclopirox Olamine Oral; Other: Placebo
ATL-001 4 mg/kg vs Placebo	Experimental	Cohort 5: ATL-001 at 4 mg/kg or Placebo (depending on randomization) will be administered during 5 days Receives: Drug: Ciclopirox Olamine Oral; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of adverse events (AEs)
Incidence of adverse events (AEs) and of clinically relevant changes in vital signs values, electrocardiogram (ECG) data, physical examination and laboratory safety data for four different doses of ATL-001
Measured: 3.5 months, with up to 66 days per participant

Secondary outcomes (7)

Derived pharmacokinetic parameters for ATL-001
Area under the plasma drug concentration
Measured: 6 days per participant
Derived pharmacokinetic parameters for ATL-001
Time curve (AUC(0-last), AUC(0-12), AUC(0-24))
Measured: 6 days per participant
Derived pharmacokinetic parameters for ATL-001
Maximum observed plasma drug concentration (Cmax)
Measured: 6 days per participant
Derived pharmacokinetic parameters for ATL-001
Time to maximum observed plasma drug concentration (tmax)
Measured: 6 days per participant
Derived pharmacokinetic parameters for ATL-001
Apparent terminal half-life (t1/2)
Measured: 6 days per participant
Derived pharmacokinetic parameters for ATL-001
Apparent total body clearance (CL/F)
Measured: 6 days per participant
Derived pharmacokinetic parameters for ATL-001
Apparent volume of distribution (Vz/F)
Measured: 6 days per participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 20238 Apr 2024

First posted12 Dec 2022
Study start31 Mar 2023
Primary completion8 Apr 2024
Study completion8 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Adverse Effect of Drugs and Medicaments in Therapeutic UseStudies 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05647343
Sponsor's protocol ID: ATL001-PI-CEP
Status last verified: Jul 2024
First submitted: 22 Nov 2022
Last updated: 24 Jul 2024
Results posted: No
Data monitoring committee: Yes
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 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety and Pharmacokinetics of ATL-001 (Ciclopirox Olamine) in Healthy Volunteers
ClinicalTrials.gov ID: NCT05647343
Acronym / sponsor ID: ATL001-PI-CEP
Conditions: Adverse Effect of Drugs and Medicaments in Therapeutic Use
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Atlas Molecular PharmaIndustry (pharma, biotech, devices)
Study start: 31 Mar 2023 (actual)
Primary completion: 8 Apr 2024 (actual)
Study completion: 8 Apr 2024 (actual)
First posted: 12 Dec 2022 (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 assess the safety, tolerability and pharmacokinetics of ATL-001 (ciclopirox olamine) in healthy volunteers

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
ATL-001 0.2 mg/kg vs Placebo	Experimental	Drug: Ciclopirox Olamine Oral, Other: PlaceboCohort 1: ATL-001 at 0.2 mg/kg or Placebo (depending on randomization) will be administered during 5 days
ATL-001 0.5 mg/kg vs Placebo	Experimental	Drug: Ciclopirox Olamine Oral, Other: PlaceboCohort 2: ATL-001 at 0.5 mg/kg or Placebo (depending on randomization) will be administered during 5 days
ATL-001 1 mg/kg vs Placebo	Experimental	Drug: Ciclopirox Olamine Oral, Other: PlaceboCohort 3: ATL-001 at 1 mg/kg or Placebo (depending on randomization) will be administered during 5 days
ATL-001 2 mg/kg vs Placebo	Experimental	Drug: Ciclopirox Olamine Oral, Other: PlaceboCohort 4: ATL-001 at 2 mg/kg or Placebo (depending on randomization) will be administered during 5 days
ATL-001 4 mg/kg vs Placebo	Experimental	Drug: Ciclopirox Olamine Oral, Other: PlaceboCohort 5: ATL-001 at 4 mg/kg or Placebo (depending on randomization) will be administered during 5 days

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Healthy male or female subjects 18 to 65 years of age, inclusive
Body mass index (BMI) within the range of 18.0 to 33.0 kg/m2, inclusive, and a minimum weight of at least 50.0 and maximum weight of 100.0 kg at Screening
Estimated Glomerular Filtration Rate (eGFR) > 90 mL/min/1.73 m2 at Screening
Female subjects of childbearing potential must be using and willing to continue using two medically acceptable contraceptive precautions from Screening and for at least 1 month after the last study drug administration. Medically acceptable forms of contraception include sexual abstinence [periodic abstinence (e.g., calendar, ovulation, symptothermal and post-ovulation methods) are not acceptable], combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), intrauterine devices (IUD), intrauterine hormone-releasing systems, and bilateral tubal ligation for subjects
Female subjects of non-childbearing potential must be amenorrhoeic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy/salpingo-oophorectomy (as determined by subject medical history)

Key exclusion criteria (14 listed)

Current drug or alcohol dependence (excluding caffeine), based on self-report, including subjects who have been in a drug rehabilitation program
Current smoker or a history of using tobacco products within 3 months prior to Screening
Clinically significant abnormalities on physical examination, medical history, 12-lead ECG (i.e., QTc > 440 ms for male subjects and > 450 ms for female subjects), vital signs, or laboratory values, as judged by the investigator or designee
History or presence of any clinically significant illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other condition, which in the opinion of the investigator would jeopardize the safety of the subject or the validity of the study results
Use of a non-prescription drug within 14 days prior to the first drug administration. Subjects who have taken over-the-counter medication may still be entered into the study, if in the opinion of the investigator or designee, the medication received will not interfere with the study procedures or data integrity or compromise the safety of the subject

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
Ciclopirox Olamine OralOn the morning of Day 1 to Day 5, each participant will receive a single oral dose of ATL-001 or placebo	Drug	ATL-001 0.2 mg/kg vs Placebo, ATL-001 0.5 mg/kg vs Placebo, ATL-001 1 mg/kg vs Placebo, ATL-001 2 mg/kg vs Placebo, ATL-001 4 mg/kg vs Placebo
PlaceboOn the morning of Day 1 to Day 5, each participant will receive a single oral dose of ATL-001 or placebo	Other	ATL-001 0.2 mg/kg vs Placebo, ATL-001 0.5 mg/kg vs Placebo, ATL-001 1 mg/kg vs Placebo, ATL-001 2 mg/kg vs Placebo, ATL-001 4 mg/kg vs Placebo

Primary outcome

Incidence of adverse events (AEs)
Time frame: 3.5 months, with up to 66 days per participant
Incidence of adverse events (AEs) and of clinically relevant changes in vital signs values, electrocardiogram (ECG) data, physical examination and laboratory safety data for four different doses of ATL-001

7 secondary outcomes

Derived pharmacokinetic parameters for ATL-001
Time frame: 6 days per participant
Derived pharmacokinetic parameters for ATL-001
Time frame: 6 days per participant
Derived pharmacokinetic parameters for ATL-001
Time frame: 6 days per participant
Derived pharmacokinetic parameters for ATL-001
Time frame: 6 days per participant
Derived pharmacokinetic parameters for ATL-001
Time frame: 6 days per participant
Derived pharmacokinetic parameters for ATL-001
Time frame: 6 days per participant
Derived pharmacokinetic parameters for ATL-001
Time frame: 6 days per participant

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 24 Jul 2024.
Individual participant dataSharing planned: No

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 Ciclopirox Olamine Oral in people with Adverse Effect of Drugs and Medicaments in Therapeutic Use, run by Atlas Molecular Pharma 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 9 inclusion and 14 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 24 Jul 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 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?

Incidence of adverse events (AEs) (time frame: 3.5 months, with up to 66 days per participant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05647343.

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 24 Jul 2024.