Cerebrotendinous XanthomatosesPhase 1NCT06180057
Bioequivalence Study to Compare Chenodeoxycholic Acid Capsules (250mg Chenodeoxycholic Acid) Versus Chenodeoxycholic Acid Leadiant 250 mg Hard Capsules (250mg Chenodeoxycholic Acid)
A Phase 1 study testing Chenodeoxycholic acid and Chenodeoxycholic acid leadiant in people with Cerebrotendinous Xanthomatoses, run by Humanis Saglık Anonim Sirketi at 1 site in Jordan.
Trial summary
Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Chenodeoxycholic acid capsules (250mg chenodeoxycholic acid) [dose: 1 x 02 capsules] versus Chenodeoxycholic acid leadiant 250 mg hard capsules (250mg chenodeoxycholic acid) [dose: 1 x 02 capsules] in healthy… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebrotendinous Xanthomatoses
- What is being tested?
- Chenodeoxycholic acid and Chenodeoxycholic acid leadiant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJordan
- Study dates
- 12 Jun 2022to 15 Aug 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is Caucasian \& aged between eighteen to fifty years (18 - 50), both inclusive.
- The subject is within the limits for his height \& weight as defined by the body mass index range (18.5 - 25.0 Kg/m2).
- The subject is willing to undergo the necessary pre- \& post- medical examinations set by this study.
- The results of medical history, vital signs, physical examination \& conducted medical laboratory tests are normal as determined by the clinical investigator.
- The subject tested negative for Hepatitis B (HBsAg), Hepatitis C (HCVAb) and human immunodeficiency virus (HIVAb).
- There is no evidence of psychiatric disorder, antagonistic personality and poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
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- The subject is able to understand and willing to sign the informed consent form.
- For female subjects: negative serum pregnancy test and the woman is using a reliable contraception method.
- The subject has normal cardiovascular system \& ECG recording.
- The subject kidney and liver (aminotransferase \& Alanine transaminase enzymes) functions tests are within normal range. (Creatinine is accepted if below the reference range after being evaluated by the CI as clinically not significant).
- The subject has normal Triglyceride (0.1-150 mg/dl), HDL (35-55 mg/dl), LDL (0.1-159 mg/dl) and Total Cholesterol levels (0.1-200 mg/dl) or clinical insignificant based on CI evaluation.
Who cannot join
- The subject is a heavy smoker (more than 10 cigarettes per day).
- The subject has suffered an acute illness one week before dosing.
- The subject has a history of or concurrent abuse of alcohol.
- The subject has a history of or concurrent abuse of illicit drugs.
- The subject has a history of hypersensitivity and/or contraindications to the study drug; including its excipients and any related compounds.
- The subject has been hospitalized within three months before the study or during the study.
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- The subject is on special diet (for example subject is vegetarian.)
- The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two days before dosing and until 72 hours after dosing in both study periods.
- The subject has taken a prescription medication within two weeks or even an over the counter product (OTC) within one week before dosing in each study period and any time during the study, unless otherwise judged acceptable by the clinical investigator.
- The subject has taken grapefruit/orange containing beverages or foodstuffs within seven (7) days before first dosing and any time during the study.
- The subject has been participating in any clinical study (e.g. pharmacokinetics, bioavailability and bioequivalence studies) within the last 80 days prior to the present study.
- The subject has donated blood within 80 days before first dosing.
- The subject has a history or presence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinal, immunological, dermatological, neurological, musculoskeletal or psychiatric diseases.
- Subject has consumed medicines or foodstuff that may affect pharmacological or pharmacokinetic properties of chenodeoxycholic acid (for example: Antacids (aluminum containing), Bile acid sequestrants such as (cholestyramine or colestipol), Clofibrate, Coumarin-derivative anticoagulants, Estrogens \& oral contraceptive) two weeks before dosing, during the study and two weeks after dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Chenodeoxycholic Acid Capsules (250mg Chenodeoxycholic Acid) [Dose: 1 x 02 Capsules] Versus Chenodeoxycholic Acid Leadiant 250 mg Hard Capsules (250mg Chenodeoxycholic Acid) [Dose: 1 x 02 Capsules] in Healthy Subjects Under Fasting Conditions
Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Chenodeoxycholic acid capsules (250mg chenodeoxycholic acid) [dose: 1 x 02 capsules] versus Chenodeoxycholic acid leadiant 250 mg hard capsules (250mg chenodeoxycholic acid) [dose: 1 x 02 capsules] in healthy subjects under fasting conditions.
- Conditions
- Cerebrotendinous Xanthomatoses
- Being tested
- Chenodeoxycholic acid, Chenodeoxycholic acid leadiant
- Medical subject headings
- Xanthomatosis, Cerebrotendinous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chenodeoxycholic acidDrug
Two capsules were administered orally
Chenodeoxycholic acid leadiantDrug
Two capsules were administered orally
| Study group | Role | What they receive |
|---|---|---|
| Chenodeoxycholic acid capsules | Experimental | Chenodeoxycholic acid capsules (250mg chenodeoxycholic acid) Receives: Drug: Chenodeoxycholic acid |
| Chenodeoxycholic acid leadiant hard capsules | Active comparator | Chenodeoxycholic acid leadiant hard capsules (250mg chenodeoxycholic acid) Receives: Drug: Chenodeoxycholic acid leadiant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Statistical analysis of primary endpoints will include descriptive statistics, Analysis of Variance (ANOVA), and Confidence Interval (CI). The average bioequivalence of the products is concluded if the two-sided 90 % CI for the test to reference ratio of the population means is within 80.00 - 125.00 % for each of the Ln-transformed data for Cmax
Measured: 72 hours
Area under the plasma concentration-time curve from time 0 to 12 hours (AUC0-12)
Statistical analysis of primary endpoints will include descriptive statistics, Analysis of Variance (ANOVA), and Confidence Interval (CI). The average bioequivalence of the products is concluded if the two-sided 90 % CI for the test to reference ratio of the population means is within 80.00 - 125.00 % for each of the Ln-transformed data for AUC0-12
Measured: 12 hours
Secondary outcomes (1)
Area under the plasma concentration-time curve from time 0 to 72 hours (AUC0-72)
The descriptive statistics for AUC0-72
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start12 Jun 2022
- Primary completion18 Jul 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrotendinous XanthomatosesStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanis Saglık Anonim Sirketi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hakan Gürpınar, Study director, Humanis Saglık
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180057
- Sponsor's protocol ID
- 1164-2022
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 28 Dec 2023
- 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 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Chenodeoxycholic Acid Capsules (250mg Chenodeoxycholic Acid) [Dose: 1 x 02 Capsules] Versus Chenodeoxycholic Acid Leadiant 250 mg Hard Capsules (250mg Chenodeoxycholic Acid) [Dose: 1 x 02 Capsules] in Healthy Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT06180057
- Acronym / sponsor ID
- 1164-2022
- Conditions
- Cerebrotendinous Xanthomatoses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Humanis Saglık Anonim SirketiIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2022 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 22 Dec 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.
Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Chenodeoxycholic acid capsules (250mg chenodeoxycholic acid) [dose: 1 x 02 capsules] versus Chenodeoxycholic acid leadiant 250 mg hard capsules (250mg chenodeoxycholic acid) [dose: 1 x 02 capsules] in healthy subjects under fasting conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chenodeoxycholic acid capsules | Experimental | Drug: Chenodeoxycholic acidChenodeoxycholic acid capsules (250mg chenodeoxycholic acid) |
| Chenodeoxycholic acid leadiant hard capsules | Active comparator | Drug: Chenodeoxycholic acid leadiantChenodeoxycholic acid leadiant hard capsules (250mg chenodeoxycholic acid) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- The subject is Caucasian \& aged between eighteen to fifty years (18 - 50), both inclusive.
- The subject is within the limits for his height \& weight as defined by the body mass index range (18.5 - 25.0 Kg/m2).
- The subject is willing to undergo the necessary pre- \& post- medical examinations set by this study.
- The results of medical history, vital signs, physical examination \& conducted medical laboratory tests are normal as determined by the clinical investigator.
- The subject tested negative for Hepatitis B (HBsAg), Hepatitis C (HCVAb) and human immunodeficiency virus (HIVAb).
Key exclusion criteria (14 listed)
- The subject is a heavy smoker (more than 10 cigarettes per day).
- The subject has suffered an acute illness one week before dosing.
- The subject has a history of or concurrent abuse of alcohol.
- The subject has a history of or concurrent abuse of illicit drugs.
- The subject has a history of hypersensitivity and/or contraindications to the study drug; including its excipients and any related compounds.
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 |
|---|---|---|
| Chenodeoxycholic acidTwo capsules were administered orally | Drug | Chenodeoxycholic acid capsules |
| Chenodeoxycholic acid leadiantTwo capsules were administered orally | Drug | Chenodeoxycholic acid leadiant hard capsules |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: 72 hours
Statistical analysis of primary endpoints will include descriptive statistics, Analysis of Variance (ANOVA), and Confidence Interval (CI). The average bioequivalence of the products is concluded if the two-sided 90 % CI for the test to reference ratio of the population means is within 80.00 - 125.00 % for each of the Ln-transformed data for Cmax
Area under the plasma concentration-time curve from time 0 to 12 hours (AUC0-12)
Time frame: 12 hours
Statistical analysis of primary endpoints will include descriptive statistics, Analysis of Variance (ANOVA), and Confidence Interval (CI). The average bioequivalence of the products is concluded if the two-sided 90 % CI for the test to reference ratio of the population means is within 80.00 - 125.00 % for each of the Ln-transformed data for AUC0-12
1 secondary outcome
Area under the plasma concentration-time curve from time 0 to 72 hours (AUC0-72)
Time frame: 72 hours
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 28 Dec 2023.
- 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.
Hakan Gürpınar study director
Humanis Saglık
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 Chenodeoxycholic acid and Chenodeoxycholic acid leadiant in people with Cerebrotendinous Xanthomatoses, run by Humanis Saglık Anonim Sirketi at 1 site in Jordan.
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 11 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 28 Dec 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 Jordan. 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?
Maximum observed plasma concentration (Cmax) (time frame: 72 hours). The study lists 2 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 28 Dec 2023.