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

Inclusion criteria

• Healthy male and female participants, between 18 and 50 years of age, inclusive.
• 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.
• 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.
• Female participant with a negative pregnancy test at Screening.
• 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.
• Participant with a BMI of 18-29.9 kg/m2.
• No clinically significant history of previous allergy / sensitivity to hydroxycarbamide or any of the excipients contained within the IMP(s).
• 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.
• Participant with a negative urinary DOA screen (including alcohol) test results, determined within 28 days before the first dose administration of the IMP.
• Participant with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV Ab) test results at Screening.
• No clinically significant abnormalities in 12-lead ECG determined within 28 days before the first dose of IMP.
• No clinically significant abnormalities in vital signs determined within 28 days before the first dose of IMP.
• Participant must be available to complete the study.
• Participant must satisfy an Investigator about his/her fitness to participate in the study.
• Participant must provide written informed consent to participate in the study.

Exclusion criteria

• A clinically significant history of gastrointestinal disorder likely to influence IMP absorption.
• 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.
• Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction.
• A clinically significant history of drug or alcohol abuse within the past two years.
• Inability to communicate well with the Investigators.
• 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.
• Donation of 450 mL or more blood within the 3 months before the first dose of IMP.
• 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
• Female participants who are pregnant, breastfeeding or lactating.
• 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.