Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 21 for:    sasa

A Bioequivalence Study to Compare the Pharmacokinetics of Two Formulations of Siklos® in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05025072
Recruitment Status : Completed
First Posted : August 27, 2021
Last Update Posted : October 7, 2021
Sponsor:
Collaborators:
Simbec Orion
Oncodesign SA
PHINC DEVELOPMENT
Information provided by (Responsible Party):
ADDMEDICA SASA

Brief Summary:

This study is a Phase I, open-label, single-centre, randomised, two-period, single-dose crossover study to compare and assess the bioequivalence, safety, tolerability and pharmacokinetics of hydroxycarbamide dispersible tablets (20 x 50 mg) (test IMP) and Siklos® film-coated tablet (1000 mg) (reference IMP) following single-dose administration. Thirty (30) healthy male and female participants, between 18 and 50 years of age are planned to participate in the study.

Study participants will be randomised to one of the 2 possible combination sequences. After each treatment administration, blood samples will be collected at specific time points to assess the Pharmacokinetics (PK) parameters.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Hydroxycarbamide dispersible tablets Drug: Hydroxycarbamide film-coated tablet Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Bioequivalence Study to Compare the Pharmacokinetics of Two Formulations of Siklos® in Healthy Volunteers
Actual Study Start Date : August 22, 2021
Actual Primary Completion Date : September 29, 2021
Actual Study Completion Date : September 29, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Hydroxyurea

Arm Intervention/treatment
Experimental: Test IMP
Hydroxycarbamide dispersible tablets (20 x 50 mg)
Drug: Hydroxycarbamide dispersible tablets
Hydroxycarbamide dispersible tablets (20 x 50 mg)

Drug: Hydroxycarbamide film-coated tablet
Hydroxycarbamide film-coated tablet (1000 mg)

Active Comparator: Reference IMP
Hydroxycarbamide film-coated tablet (1000 mg)
Drug: Hydroxycarbamide dispersible tablets
Hydroxycarbamide dispersible tablets (20 x 50 mg)

Drug: Hydroxycarbamide film-coated tablet
Hydroxycarbamide film-coated tablet (1000 mg)




Primary Outcome Measures :
  1. Cmax [ Time Frame: 24 hours ]
    The observed maximum concentration (Cmax) in plasma

  2. AUC0-t [ Time Frame: 24 hours ]
    The area under the plasma concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration (t)

  3. AUC0-infinity [ Time Frame: 24 hours ]
    The AUC from time 0 to infinity


Secondary Outcome Measures :
  1. tmax [ Time Frame: 24 hours ]
    The time at which Cmax is apparent

  2. t1/2 [ Time Frame: 24 hours ]
    The terminal elimination half-life

  3. ke [ Time Frame: 24 hours ]
    The terminal elimination rate-constant

  4. AUC%extra [ Time Frame: 24 hours ]
    % of AUC0-infinity extrapolated

  5. Adverse events [ Time Frame: 24 hours ]
    Incidence of Adverse Events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male and female participants, between 18 and 50 years of age, inclusive.
  2. Female participant of childbearing potential willing to use a highly effective method of contraception, if applicable from the first dose until 3 months after the last dose of IMP.
  3. Female participant of non-childbearing potential. For the purposes of this study, this is defined as the participant being amenorrhoeic for at least 12 consecutive months or at least 4 months post-surgical sterilisation.
  4. Female participant with a negative pregnancy test at Screening.
  5. Male participant (and partner of child bearing potential) willing to use a highly method of contraception, if applicable from first dose until 3 months after last dose of IMP.
  6. Participant with a BMI of 18-29.9 kg/m2.
  7. No clinically significant history of previous allergy / sensitivity to hydroxycarbamide or any of the excipients contained within the IMP(s).
  8. No clinically significant abnormal test results for serum biochemistry, haematology and/or urine analyses within 28 days before the first dose administration of the IMP.
  9. Participant with a negative urinary DOA screen (including alcohol) test results, determined within 28 days before the first dose administration of the IMP.
  10. Participant with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV Ab) test results at Screening.
  11. No clinically significant abnormalities in 12-lead ECG determined within 28 days before the first dose of IMP.
  12. No clinically significant abnormalities in vital signs determined within 28 days before the first dose of IMP.
  13. Participant must be available to complete the study.
  14. Participant must satisfy an Investigator about his/her fitness to participate in the study.
  15. Participant must provide written informed consent to participate in the study.

Exclusion Criteria:

  1. A clinically significant history of gastrointestinal disorder likely to influence IMP absorption.
  2. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 28 days or 5 half-lives prior to the first dose of IMP.
  3. Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction.
  4. A clinically significant history of drug or alcohol abuse within the past two years.
  5. Inability to communicate well with the Investigators.
  6. Participation in a New Chemical Entity clinical study within the previous 3 months or five half-lives whichever is the longest, or a marketed drug clinical study within the 30 days or five half-lives whichever is the longest, before the first dose of IMP.
  7. Donation of 450 mL or more blood within the 3 months before the first dose of IMP.
  8. Users of nicotine products i.e., current smokers or ex-smokers who have smoked within 6 months prior to Screening or users of cigarette replacements
  9. Female participants who are pregnant, breastfeeding or lactating.
  10. Participants who have received any live or attenuated vaccine within 28 days of the first dose of IMP, or who are planning to receive a vaccine up to 28 days after receiving the last dose of IMP in Treatment Period 2.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05025072


Locations
Layout table for location information
United Kingdom
Simbec-Orion Clinical Pharmacology
Merthyr Tydfil, United Kingdom
Sponsors and Collaborators
ADDMEDICA SASA
Simbec Orion
Oncodesign SA
PHINC DEVELOPMENT
Investigators
Layout table for investigator information
Principal Investigator: Annelize Koch, MD Simbec Orion
Layout table for additonal information
Responsible Party: ADDMEDICA SASA
ClinicalTrials.gov Identifier: NCT05025072    
Other Study ID Numbers: SIK-FR-21-1
First Posted: August 27, 2021    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ADDMEDICA SASA:
Hydroxycarbamide
Hydroxyurea
Additional relevant MeSH terms:
Layout table for MeSH terms
Hydroxyurea
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors