A Drug-drug Interaction Study to Investigate the Effects of AZD1981 on the Metabolism and Pharmacodynamics of Oral Contraceptives

Study Overview
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Brief Summary
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The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the metabolism of hormones included in oral contraceptives.

Official Title
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A Phase I, Double-blind, Randomised, Placebo-controlled, Two-cycle Crossover, Drug-drug Interaction Study to Investigate the Effects of AZD1981 Tablets 400 mg Twice Daily on the PK and PD of Oral Contraceptives in Healthy Female Volunteers

Conditions
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Oral Contraceptives

Intervention / Treatment
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* Drug: AZD1981
* Drug: Neovletta 21/28
* Drug: Placebo AZD1981


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females of childbearing potential Use of Neovletta or Neovletta 28 minimum 3 months prior to enrolment. Willing to use a highly effective method of birth control, ie, double barrier method contraception. Exclusion Criteria: Pregnancy and/or lactation or delivery/abortion within 6 months prior to randomisation. Any clinically significant disease or disorder. Any clinically relevant abnormal findings in physical examination.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD1981 + Oral contraceptive | Drug: AZD1981<br>* 4X100 mg per oral, twice daily for 28 days<br>Drug: Neovletta 21/28<br>* Once daily with (21) or without (28) pause for bleeding.<br>|
| Placebo Comparator: 2<br>Placebo + Oral contraceptive | Drug: Neovletta 21/28<br>* Once daily with (21) or without (28) pause for bleeding.<br>Drug: Placebo AZD1981<br>* 4X100 mg per oral, twice daily for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of of EE and LNG by analysis of the AUC and Css,max. |  | PK sampling will be performed regularly during the study period of two months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on LH, FSH, SHBG, progesterone, and E2 during the menstrual cycle: Serum concentrations of LH, FSH, SHBG, progesterone and E2 |  | PD sampling will be done at the end of treatment period 1 and 2. | 
| Safety and tolerability of the combination: Adverse events, safety laboratory variables, pulse, blood pressure, electrocardiogram and physical examinations |  | Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study. | 
| Steady state PK of 1981 in combo with oral contraceptives AUCτ, Css,max, time to Cmax during a dosing interval (tmax ss);apparent plasma clearance (CLss/F) of AZD1981(tmax ss) of EE and LNG; Morning Ctrough values of EE and LNG will be measured. |  | PK-sampling of AZD1981 wil be done at the end of treatment period 1 and 2. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, Drug-drug interaction, Oral contraceptives, AZD 1981