Metformin Clinical Trial
Official title:
Inter- and Intra-individual Variations in Metformin Pharmacokinetics - The Importance of Genes and Drug Interactions
NCT number | NCT03335423 |
Other study ID # | 1779 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | March 1, 2018 |
Est. completion date | June 13, 2020 |
Verified date | January 2018 |
Source | University of Southern Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators aim to investigate the interindividual variation in metformin AUC in a
large cohort of healthy volunteers after a single dose of metformin. Part 1 is driven by the
hypothesis that metformin AUC and renal clearance exhibit significant interindividual
variation. However this has never been documented in a large cohort of healthy volunteers.
The investigators aim to investigate the potential interaction between codeine and metformin
in the intestine. The hypothesis underlying part 3 is that the increased risk of early
discontinuation of metformin during co-administration with codeine is primarily due to local
inhibition of OCT1 via codeine at the intestinal level.
Status | Completed |
Enrollment | 228 |
Est. completion date | June 13, 2020 |
Est. primary completion date | June 13, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria Part 1 (and 2): Men and women. Apparent good general health. eGFR,
creatinine, Hba1c, must be within the reference range or clinically insignificantly differ
from this. Written consent must be given. Age 18-65. BMI 18,5 - 29,9kg/m². - Exclusion Criteria part 1 (and 2): Daily consumption of medicine (prescription, over the counter and herbal medicines, dietary supplements (oral contraceptives and regular vitamin pills are accepted)). Alcohol abuse. Hypersensitivity for metformin. For women: positive pregnancy test and not using safe contraceptives for 24 hours after intake of metformin and breastfeeding. Inclusion Criteria Part 3:Apparent good general health. eGFR, creatinine, Hba1c, glucose, ALAT and bilirubin must be within the reference range or clinically insignificantly differ from this. Written consent must be given. Age 18-30 . BMI 18,5 - 29,9kg/m². Exclusion Criteria part 3: Daily consumption of medicine (prescription, over the counter and herbal medicines, dietary supplements (regular vitamin pills are accepted)). Alcohol abuse. Hypersensitivity for metformin, codeine or morphine. Genetically proven CYP2D6 slow or ultra-fast metabolizers. Genetically proven loss-of-function allele in OCT1 - |
Country | Name | City | State |
---|---|---|---|
Denmark | The department of clinical pharmacy and pharmacology | Odense |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Metformin AUC | Outcomes of part 1: Variation in metformin AUC in a large cohort of healthy volunteers after a single dose of metformin | blood samples will be collected after 3 and 10 hours for each subject (N=300) after oral metformin ingestion. Urine is collected for 24 hours. | |
Primary | Metformin AUC | Outcome of part 3; differences in AUC for metformin when given alone and together with codeine | Blood samples will be drawn in each of the 4 arms from ingestion of the drug/drugs and for 24 hours at suitable times. Urine is collected after ingestion of metformin for 24 hours. | |
Secondary | Codeine AUC | secondary outcome of part 3: differences in codeine AUC when codeine is given alone and together with metformin | Blood samples are collected for 6 hours after ingestion of the first codeine pill. Blood samples are also collected and measured for codeine, morphing, M3G,M6G for 6 hours after both oral and intravenous metformin | |
Secondary | Lactate AUC | Secondary outcome of part 3: differences in lactate AUC after metformin is given orally and intravenously | Blood samples for lactate will be drawn in each arm after metformin ingestion for 24 hours at suitable times |
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