Dept. of Human Pharmacology
Aachen, 52078, Germany
NCT Number: NCT03765801
The aim of this clinical study in healthy women is to explore the intestinal uptake (bioavailability) of two different tablets of GRTA9906 (formulations) into the body and the effect of food on it. The intake of food may considerably influence the bioavailability, either by interaction with the compound itself or, if a prolonged release (PR) formulation is used, with the components of the tablet-matrix. For these reasons, the relative bioavailability and the effect of food on the bioavailability of GRTA9906 given as PR tablets compared to immediate release (IR) capsules will be assessed in this study.
During the 4 periods of the study, each participant will receive two 60 mg GRTA9906 PR matrix tablets and two 60 mg GRTA9906 IR capsules under fed conditions (after consumption of a high-fat and high-calorie test meal) and fasting conditions (10 hours before dosing until 4.5 hours after dosing). In each period, the participant will receive the investigational product once.
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Notify Me18 year–55 year
Female
Interventional
Phase 1
Aachen, 52078, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
GRTA9906 60 mg PR tablet
GRTA9906 60 mg IR capsule
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Area under the concentration vs. time curve from dosing time to the last measured concentration above the lower limit of quantitation. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Total area under the concentration vs. time curve (from dosing time to infinity). The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Time to reach maximum serum concentration. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Maximum serum concentration. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Period of time from the administration of the investigational product to the first measured concentration. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Apparent terminal half-life. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Mean residence time. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Half-value duration. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Total clearance. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Apparent volume of distribution during the terminal phase. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Time frame: pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 10 and 23 hours post-dose
Diameter in millimeter (mm) before presentation of the light stimulus. Pupillometry will be carried out using a Compact Integrated Pupillograph (CIP) in a darkened room.
Time frame: pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 10 and 23 hours post-dose
Time in seconds (sec) between begin of the light stimulus and onset of pupil reaction.
Time frame: pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 10 and 23 hours post-dose
Difference in millimeter (mm) between initial value and minimum diameter.
Time frame: pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 10 and 23 hours post-dose
Time in seconds (sec) between onset of reaction and minimum diameter.
Grünenthal GmbH
Industry
Phase I, Single-center Study to Explore the Relative Bioavailability and the Effect of Food on the Bioavailability of Prolonged Release Tablets Compared to Immediate Release Capsules Each Containing 60 mg of GRTA9906 in 20 Healthy Female Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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