HealthyEarly Phase 1NCT05817890
Absorption, Metabolism, and Excretion of CYC065 in Healthy Male Subjects
A Early Phase 1 study testing Fadraciclib in people with Healthy, run by Cyclacel Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This will be a Phase 1, open-label, single dose study of the Absorption, Metabolism, and Excretion of CYC065 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fadraciclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2023to 22 May 2024
- Phase
- Early 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males, of any race, between 18 and 55 years of age, inclusive.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, with a total body weight ≥50 kg.
- In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations at screening and check-in and from the physical examination at check-in, as assessed by the investigator (or designee).
- Males will agree to use contraception.
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- History of a minimum of 1 bowel movement per day.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- Confirmed (eg, 2 consecutive measurements) systolic blood pressure >140 mmHg or <90 mmHg, diastolic blood pressure >90 mmHg or <50 mmHg, and pulse rate >100 beats per minute or <40 beats per minute.
- Positive hepatitis panel and/or positive human immunodeficiency virus test.
Trial locations and contacts
1 site in 1 country.
United States1 site
Labcorp Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-CYC065 Following a Single Oral Dose in Healthy Male Subjects
This will be a Phase 1, open-label, single dose study of the Absorption, Metabolism, and Excretion of CYC065 in healthy male subjects.
Read the detailed description
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the study site on Day -1 and be confined to the study site until at least Day 8 (168 hours post dose). On Day 1, subjects will receive a single oral dose of [14C]-CYC065. Subjects will be discharged if the following discharge criteria are met: plasma radioactivity levels below the limit of quantitation for 2 consecutive collections, ≥90% mass balance recovery, and ≤1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive 24-hour periods. If discharge criteria are not met by Day 8, subjects will remain in the study site until all discharge criteria are met up to a maximum of Day 15.
- Conditions
- Healthy
- Being tested
- Fadraciclib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FadraciclibDrug
Also called CYC065
Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-CYC065 Following a Single Oral Dose in Healthy Male Subjects
| Study group | Role | What they receive |
|---|---|---|
| Up to 8 subjects will be enrolled and studied as a single group | Experimental | The purpose of this study is to determine the absorption, metabolism, and excretion (AME) of [14C]CYC065 and to characterize and determine, where possible, the metabolites present in plasma, urine, and feces in healthy male subjects following a single oral administration. Receives: Drug: Fadraciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The routes, rates of elimination, and mass balance
Total radioactivity from [14C]-CYC065 recovery (fet1t2) in urine and feces
Measured: Up to Day 15
AUC for CYC065 in plasma
To characterize the PK of CYC065 and total radioactivity following administration of [14C]CYC065 to healthy subjects
Measured: Up to Day 15
Cmax for CYC065 in plasma
To characterize the PK of CYC065 and total radioactivity following administration of [14C]CYC065 to healthy subjects
Measured: Up to Day 15
Tmax for CYC065 in plasma
To characterize the PK of CYC065 and total radioactivity following administration of [14C]CYC065 to healthy subjects
Measured: Up to Day 15
t½ for CYC065 in plasma
To characterize the PK of CYC065 and total radioactivity following administration of [14C]CYC065 to healthy subjects
Measured: Up to Day 15
Secondary outcomes (2)
Concentration of CYC065 metabolites
To determine, where possible, the quantitative metabolite profiles in plasma, urine, and feces after [14C]CYC065
Measured: Up to Day 15
Incidence and severity of AEs
To assess the safety and tolerability of [14C]CYC065 when administered to healthy subjects
Measured: Up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start3 Mar 2023
- Primary completion29 Feb 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817890
- Sponsor's protocol ID
- CYC065-902
- Status last verified
- Sep 2024
- First submitted
- 2 Mar 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-CYC065 Following a Single Oral Dose in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05817890
- Acronym / sponsor ID
- CYC065-902
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 18 Apr 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 will be a Phase 1, open-label, single dose study of the Absorption, Metabolism, and Excretion of CYC065 in healthy male subjects.
Detailed description
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the study site on Day -1 and be confined to the study site until at least Day 8 (168 hours post dose). On Day 1, subjects will receive a single oral dose of [14C]-CYC065. Subjects will be discharged if the following discharge criteria are met: plasma radioactivity levels below the limit of quantitation for 2 consecutive collections, ≥90% mass balance recovery, and ≤1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive 24-hour periods. If discharge criteria are not met by Day 8, subjects will remain in the study site until all discharge criteria are met up to a maximum of Day 15.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Up to 8 subjects will be enrolled and studied as a single group | Experimental | Drug: FadraciclibThe purpose of this study is to determine the absorption, metabolism, and excretion (AME) of [14C]CYC065 and to characterize and determine, where possible, the metabolites present in plasma, urine, and feces in healthy male subjects following a single oral administration. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males, of any race, between 18 and 55 years of age, inclusive.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, with a total body weight ≥50 kg.
- In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations at screening and check-in and from the physical examination at check-in, as assessed by the investigator (or designee).
- Males will agree to use contraception.
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Key exclusion criteria (5 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- Confirmed (eg, 2 consecutive measurements) systolic blood pressure >140 mmHg or <90 mmHg, diastolic blood pressure >90 mmHg or <50 mmHg, and pulse rate >100 beats per minute or <40 beats per minute.
- Positive hepatitis panel and/or positive human immunodeficiency virus test.
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 |
|---|---|---|
| FadraciclibAlso: CYC065Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-CYC065 Following a Single Oral Dose in Healthy Male Subjects | Drug | Up to 8 subjects will be enrolled and studied as a single group |
Primary outcome
The routes, rates of elimination, and mass balance
Time frame: Up to Day 15
Total radioactivity from [14C]-CYC065 recovery (fet1t2) in urine and feces
AUC for CYC065 in plasma
Time frame: Up to Day 15
To characterize the PK of CYC065 and total radioactivity following administration of [14C]CYC065 to healthy subjects
Cmax for CYC065 in plasma
Time frame: Up to Day 15
To characterize the PK of CYC065 and total radioactivity following administration of [14C]CYC065 to healthy subjects
Tmax for CYC065 in plasma
Time frame: Up to Day 15
To characterize the PK of CYC065 and total radioactivity following administration of [14C]CYC065 to healthy subjects
t½ for CYC065 in plasma
Time frame: Up to Day 15
To characterize the PK of CYC065 and total radioactivity following administration of [14C]CYC065 to healthy subjects
2 secondary outcomes
Concentration of CYC065 metabolites
Time frame: Up to Day 15
Incidence and severity of AEs
Time frame: Up to Day 15
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 19 Sep 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.
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 Early Phase 1 study testing Fadraciclib in people with Healthy, run by Cyclacel 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 6 inclusion and 5 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 19 Sep 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The routes, rates of elimination, and mass balance (time frame: Up to Day 15). The study lists 5 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 19 Sep 2024.