Phase 1, first-in-human trial to evaluate the safety, tolerability, and pharmacokinetics of ascending single oral doses of octreotide/ LipOra-Peptide in healthy volunteers - LipOra trial

niversität Heidelberg vertreten durch das Universitätsklinikum0 sites95 target enrollmentJuly 14, 2023

Overview

No summary available.

Registry

who.int

Start Date

July 14, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

niversität Heidelberg vertreten durch das Universitätsklinikum

•Men and women of childbearing potential (WOCBP) who are willing to use a highly effective method of contraception during the treatment and 7 d after the last administration of the investigational medicinal product (IMP), or women of no childbearing potential (WNCBP) \[defined as women who underwent surgical sterilization (hysterectomy, bilateral oophorectomy or bilateral tubal ligation) or cessation of menses for 12 or more consecutive months and a follicle stimulating hormone (FSH) test with FSH levels 40 mIU/ml], or individuals who are convincingly sexually abstinent,
•\- An understanding, ability, and willingness to fully comply with study interventions and restrictions,
•\- Ability to provide written, personally signed and dated informed consent to participate in the study, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study\-related interventions.
•\- Body mass index \< 30 kg/m2,
•\- Willingness to follow the pertinent guidelines for prevention of spreading SARS\-CoV2 based on SOPs of the hospital administration of the trial site. This may include a SARS\-CoV2 testing and proof of vaccination. These rules may change during the course of the trial.

•At the time of SCR
•1\. Clinically significant or relevant abnormalities in the medical history, physical examination, and laboratory evaluation as assessed by the investigator,
•2\. Ongoing or past history of physical or psychiatric illness judged by the investigator as clinically relevant,
•3\. Pregnancy or breast feeding,
•4\. Any acute or chronic illness or clinically relevant finding known or expected to modify absorption, distribution, metabolism, or excretion of OTT,
•5\. Any known history of severe allergic or anaphylactic reactions to drugs or food or any other clinically significant allergies,
•6\. Any known allergies to OTT or further ingredients of the trial drugs,
•7\. Clinically relevant findings in any of the following investigations at SCR. Minor deviations of laboratory values from the normal range may be accepted if, in the opinion of the investigator, they have no clinical significance for this trial,
•a) Hemoglobin (Hb) \< 12 g/dl (males) or \< 11 g/dl (females),
•b) Creatinine clearance \< 60 ml/min (Cockcroft\-Gault),