Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 3/1/2019 |
| Start Date: | March 8, 2019 |
| End Date: | June 14, 2019 |
A Phase 1, Open-Label, Parallel, Sequential, Multi-part Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of an Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers
The primary objectives of this study are the following:
- To evaluate the pharmacokinetics (PK) of a monophasic oral contraceptive's active
components, ethinyl estradiol (EE) and norethindrone acetate (NET), following a single
oral dose alone and in combination with IW-3718 in healthy adult female participants.
- To evaluate the PK of levothyroxine following a single oral dose alone and in
combination with IW-3718 in healthy adult participants.
- To evaluate the PK of glyburide following a single oral dose alone and in combination
with IW-3718 in healthy adult participants.
- To evaluate the PK of digoxin following a single oral dose alone and in combination with
IW-3718 in healthy adult participants.
- To evaluate the pharmacokinetics (PK) of a monophasic oral contraceptive's active
components, ethinyl estradiol (EE) and norethindrone acetate (NET), following a single
oral dose alone and in combination with IW-3718 in healthy adult female participants.
- To evaluate the PK of levothyroxine following a single oral dose alone and in
combination with IW-3718 in healthy adult participants.
- To evaluate the PK of glyburide following a single oral dose alone and in combination
with IW-3718 in healthy adult participants.
- To evaluate the PK of digoxin following a single oral dose alone and in combination with
IW-3718 in healthy adult participants.
Inclusion Criteria:
- Is healthy, ambulatory, and 18-50 years of age (inclusive) at screening visit.
- Weighs at least 50 kg and has a body mass index within 18-35 kg/m2 at the screening
visit.
- Is not pregnant or breastfeeding at the time of the screening visit and has negative
serum pregnancy tests at the screening visit and check-in.
- Other inclusion criteria per protocol.
Exclusion Criteria:
- Has used any prescription drugs, herbal supplements, over-the-counter medication, or
dietary supplements (vitamins included) within 4 weeks prior to dosing. If needed,
(ie, incidental and limited need), acetaminophen is acceptable.
- Has consumed grapefruit or grapefruit juice within 4 weeks prior to dosing or plans to
consume grapefruit or grapefruit juice before 7 days following the last dose.
- Has a significant illness that has not resolved within 2 weeks prior to dosing.
- Has a history of immunodeficiency diseases, including a positive human
immunodeficiency virus test result.
- Has a positive hepatitis B surface antigen or hepatitis C antibody test result.
- Is a smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine
patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6 months before the
first dose of study drug.
- Other exclusion criteria per protocol.
We found this trial at
1
site
Click here to add this to my saved trials
