BridgeMD
A Pilot Open-label, Randomized, Crossover, Comparative Bioavailability Study of Levodopa Administered via Levodopa Cyclops™ (test product) Relative to INBRIJA® (reference product) in Healthy Adult Subjects
EU CTIS ID: 2023-504687-42-00
What this study is testing
The primary objective of the present trial is to determine the dose at which comparative bioavailability of levodopa will be reached between Levodopa Cyclops™ versus Inbrija® in healthy adult subjects after an oral inhalation of a single dose of 45, 90 and 135 mg levodopa under fasting conditions administered with 50 mg carbidopa one hour prior IMP administration in 3 study periods and after a single dose of 66 mg levodopa delivered dose (2 hard capsules containing 42 mg levodopa each) of Inbrija® administered with carbidopa 50 mg one hour prior to IMP administration in a fourth study period.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- [1] Male or female subject
- [2] Age between 18 and 55 years (inclusive the date of signing informed consent)
- [3] Female subject who IS NOT of reproductive potential. A female subject who is NOT of reproductive potential is defined as one who: (i) has reached natural menopause (defined as at least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone [FSH] levels in the postmenopausal range as determined by the local laboratory, or 12 months of spontaneous amenorrhea); (ii) is 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or (iii) has undergone bilateral tubal ligation. Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (e.g. anorexia nervosa)
- [4] Female subject who IS of reproductive potential and uses reliable contraception method and/or is willing to use adequate birth control methods starting from the time of consent through 30 days after the last dose of study therapy
- [5] Physically and mentally healthy as judged by means of medical and standard laboratory examination
- [6] Non-smokers or ex-smokers (stopped at least 6 months ago) with a smoking history of ≤5 pack-year equivalents (1 pack-year equivalent is equal to smoking 1 pack per day for 1 year) and non-users of other nicotine containing products, confirmed by urine cotinine test
You likely can't join if
- [1] Participation in another clinical trial at same time or within 90 days before screening visit (calculated from the date of the final examination of the previous study)
- [10] Positive alcohol test
- [11] History of significant multiple and/or severe allergies (including latex allergy, asthma or bronchial hyperreactivity), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
- [12] Any history of drug hypersensitivity (especially to the active ingredient levodopa of the Test and Reference IMPs and to the active ingredient carbidopa of the AxMP) or intolerance to any sugar (e.g. fructose, glucose, or lactose)
- [13] Presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, hematological, gastrointestinal, neurological, psychiatric or other diseases
- [14] Clinically significant illness within 4 weeks before screening visit
See the full eligibility criteria
Who can join
- [1] Male or female subject
- [2] Age between 18 and 55 years (inclusive the date of signing informed consent)
- [3] Female subject who IS NOT of reproductive potential. A female subject who is NOT of reproductive potential is defined as one who: (i) has reached natural menopause (defined as at least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone [FSH] levels in the postmenopausal range as determined by the local laboratory, or 12 months of spontaneous amenorrhea); (ii) is 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or (iii) has undergone bilateral tubal ligation. Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (e.g. anorexia nervosa)
- [4] Female subject who IS of reproductive potential and uses reliable contraception method and/or is willing to use adequate birth control methods starting from the time of consent through 30 days after the last dose of study therapy
- [5] Physically and mentally healthy as judged by means of medical and standard laboratory examination
- [6] Non-smokers or ex-smokers (stopped at least 6 months ago) with a smoking history of ≤5 pack-year equivalents (1 pack-year equivalent is equal to smoking 1 pack per day for 1 year) and non-users of other nicotine containing products, confirmed by urine cotinine test
- [7] BMI within the range (including the borders) of 18.0 to 30.0 kg/m2
- [8] Normal spirometry values at screening (forced expiratory volume in one second [FEV1] and forced vital capacity [FVC] between 80% and 120% of the average value regarding age, height, gender and ethnicity (acc. to ECCS/ERS)
- [9] Informed consent given in written form according to chapter 5.4 of clinical trial protocol
What rules you out
- [1] Participation in another clinical trial at same time or within 90 days before screening visit (calculated from the date of the final examination of the previous study)
- [10] Positive alcohol test
- [11] History of significant multiple and/or severe allergies (including latex allergy, asthma or bronchial hyperreactivity), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
- [12] Any history of drug hypersensitivity (especially to the active ingredient levodopa of the Test and Reference IMPs and to the active ingredient carbidopa of the AxMP) or intolerance to any sugar (e.g. fructose, glucose, or lactose)
- [13] Presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, hematological, gastrointestinal, neurological, psychiatric or other diseases
- [14] Clinically significant illness within 4 weeks before screening visit
- [15] Major surgery of the gastrointestinal tract except for appendectomy
- [16] Any chronic disease which might interfere with resorption, distribution, metabolism or excretion of the drug
- [17] History of difficulty in swallowing
- [18] Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies
- [19] Administration of depot injectable solutions or medications with a half-life >1 week (including study medications) within 6 months before screening visit
- [2] Randomization into the present trial more than once
- [20] Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before screening visit
- [21] Intake or administration of any systemic or topical medication (including OTC medication and especially intake of antacids e.g. aluminum hydroxide, magnesium hydroxide, and simethicone or herbal medication e.g. St. John's wort, kava kava) within 2 weeks before screening visit
- [22] Medication with drugs known to alter the major organs or systems such as barbiturates, phenothiazines, cimetidine, omeprazole etc. within 60 days before screening visit
- [23] Systolic blood pressure outside the range of 100 to 135 mmHg and/or diastolic blood pressure outside the range of 60 to 90 mmHg
- [24] Pulse rate outside the range of 50 to 90 beats/min
- [25] Respiratory rate outside the range of 12-16 breaths/min
- [26] Axillary body temperature outside the interval of 35.5 to 37.1°C
- [27] Any clinically significant abnormality of the resting ECG (12-lead)
- [28] Laboratory values outside normal range with clinical relevance
- [29] Special diet due to any reason, e.g. vegetarians
- [3] Pregnant and/or nursing women. Positive pregnancy test
- [30] Subjects who are known or suspected: - not to comply with the study directives; - not to be reliable or trustworthy; - not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed; - to be in such a precarious financial situation that they no longer weigh up the possible risks of their participation and the unpleasantness they may be involved in - subject is in custody or submitted to an institution due to a judicial order.
- [4] Weight of less than 40 kg
- [5] Blood donation or blood loss including plasmapheresis of >500 mL within 90 days before screening visit
- [6] History of drug abuse or use of illegal drugs: use of soft drugs, e.g. marihuana within 6 months before screening visit or hard drugs, e.g. cocaine, amphetamines, phencyclidine within 1 year before screening visit
- [7] Alcohol abuse, i.e. regular use of more than 2 units of alcohol per day or 10 units per week or a history of alcoholism (one unit of alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits) or recovered alcoholics
- [8] Regular consumption of beverages or food containing methylxanthines (e.g. coffee, tea, cola, caffeine containing sodas, chocolate) equivalent to more than 500 mg methylxanthines per day
- [9] Positive drug screening
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.